Trial Outcomes & Findings for Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy (NCT NCT01598831)

NCT ID: NCT01598831

Last Updated: 2020-04-21

Results Overview

28-Day All-cause Mortality

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 816 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2020-04-21

Participant Flow

This study was conducted at 319 sites in 27 countries; of these, 159 study sites (in 26 countries) assigned participants to study drug treatment. First participant was randomized on Oct 29, 2012 and the last participant was randomized on Mar 8, 2018. Last participant completed long term follow-up (survival only) on Feb 28, 2019.

Of 946 consented participants, 816 randomized to study treatment, 800 received at least 1 dose of study treatment.

Participant milestones

Measure	ART-123 ART-123 (human recombinant thrombomodulin, thrombomodulin alfa) Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days	Placebo Placebo Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
Overall Study STARTED	402	414
Overall Study Received at Least 1 Dose Study Treatment	395	405
Overall Study COMPLETED	283	278
Overall Study NOT COMPLETED	119	136

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One subject in the ART-123 arm and one in the Placebo arm did not have baseline height recorded in the eCRF

Baseline characteristics by cohort

Measure	ART-123 n=395 Participants ART-123 (human recombinant thrombomodulin, thrombomodulin alfa) Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days	Placebo n=405 Participants Placebo Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days	Total n=800 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=395 Participants	0 Participants n=405 Participants	0 Participants n=800 Participants
Age, Categorical Between 18 and 65 years	231 Participants n=395 Participants	231 Participants n=405 Participants	462 Participants n=800 Participants
Age, Categorical >=65 years	164 Participants n=395 Participants	174 Participants n=405 Participants	338 Participants n=800 Participants
Age, Continuous	61.0 years STANDARD_DEVIATION 15.87 • n=395 Participants	60.5 years STANDARD_DEVIATION 15.94 • n=405 Participants	60.7 years STANDARD_DEVIATION 15.89 • n=800 Participants
Sex: Female, Male Female	179 Participants n=395 Participants	184 Participants n=405 Participants	363 Participants n=800 Participants
Sex: Female, Male Male	216 Participants n=395 Participants	221 Participants n=405 Participants	437 Participants n=800 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=395 Participants	22 Participants n=405 Participants	42 Participants n=800 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	290 Participants n=395 Participants	285 Participants n=405 Participants	575 Participants n=800 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	85 Participants n=395 Participants	98 Participants n=405 Participants	183 Participants n=800 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=395 Participants	8 Participants n=405 Participants	13 Participants n=800 Participants
Race (NIH/OMB) Asian	56 Participants n=395 Participants	58 Participants n=405 Participants	114 Participants n=800 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=395 Participants	2 Participants n=405 Participants	3 Participants n=800 Participants
Race (NIH/OMB) Black or African American	14 Participants n=395 Participants	20 Participants n=405 Participants	34 Participants n=800 Participants
Race (NIH/OMB) White	312 Participants n=395 Participants	308 Participants n=405 Participants	620 Participants n=800 Participants
Race (NIH/OMB) More than one race	7 Participants n=395 Participants	9 Participants n=405 Participants	16 Participants n=800 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=395 Participants	0 Participants n=405 Participants	0 Participants n=800 Participants
Region of Enrollment United States	34 Participants n=395 Participants	37 Participants n=405 Participants	71 Participants n=800 Participants
Region of Enrollment Czechia	10 Participants n=395 Participants	11 Participants n=405 Participants	21 Participants n=800 Participants
Region of Enrollment Russia	54 Participants n=395 Participants	57 Participants n=405 Participants	111 Participants n=800 Participants
Region of Enrollment Greece	0 Participants n=395 Participants	1 Participants n=405 Participants	1 Participants n=800 Participants
Region of Enrollment Netherlands	22 Participants n=395 Participants	27 Participants n=405 Participants	49 Participants n=800 Participants
Region of Enrollment South Korea	4 Participants n=395 Participants	2 Participants n=405 Participants	6 Participants n=800 Participants
Region of Enrollment Brazil	11 Participants n=395 Participants	8 Participants n=405 Participants	19 Participants n=800 Participants
Region of Enrollment Bulgaria	1 Participants n=395 Participants	1 Participants n=405 Participants	2 Participants n=800 Participants
Region of Enrollment France	75 Participants n=395 Participants	74 Participants n=405 Participants	149 Participants n=800 Participants
Region of Enrollment Serbia	1 Participants n=395 Participants	1 Participants n=405 Participants	2 Participants n=800 Participants
Region of Enrollment Croatia	6 Participants n=395 Participants	5 Participants n=405 Participants	11 Participants n=800 Participants
Region of Enrollment Colombia	2 Participants n=395 Participants	0 Participants n=405 Participants	2 Participants n=800 Participants
Region of Enrollment Argentina	1 Participants n=395 Participants	0 Participants n=405 Participants	1 Participants n=800 Participants
Region of Enrollment Hungary	0 Participants n=395 Participants	1 Participants n=405 Participants	1 Participants n=800 Participants
Region of Enrollment United Kingdom	6 Participants n=395 Participants	4 Participants n=405 Participants	10 Participants n=800 Participants
Region of Enrollment India	41 Participants n=395 Participants	44 Participants n=405 Participants	85 Participants n=800 Participants
Region of Enrollment Spain	9 Participants n=395 Participants	11 Participants n=405 Participants	20 Participants n=800 Participants
Region of Enrollment New Zealand	6 Participants n=395 Participants	5 Participants n=405 Participants	11 Participants n=800 Participants
Region of Enrollment Canada	22 Participants n=395 Participants	24 Participants n=405 Participants	46 Participants n=800 Participants
Region of Enrollment Belgium	34 Participants n=395 Participants	34 Participants n=405 Participants	68 Participants n=800 Participants
Region of Enrollment Finland	18 Participants n=395 Participants	19 Participants n=405 Participants	37 Participants n=800 Participants
Region of Enrollment Taiwan	4 Participants n=395 Participants	4 Participants n=405 Participants	8 Participants n=800 Participants
Region of Enrollment Israel	9 Participants n=395 Participants	10 Participants n=405 Participants	19 Participants n=800 Participants
Region of Enrollment Australia	19 Participants n=395 Participants	19 Participants n=405 Participants	38 Participants n=800 Participants
Region of Enrollment Peru	3 Participants n=395 Participants	2 Participants n=405 Participants	5 Participants n=800 Participants
Region of Enrollment Germany	3 Participants n=395 Participants	4 Participants n=405 Participants	7 Participants n=800 Participants
Height	167.39 cm STANDARD_DEVIATION 8.729 • n=394 Participants • One subject in the ART-123 arm and one in the Placebo arm did not have baseline height recorded in the eCRF	168.02 cm STANDARD_DEVIATION 9.619 • n=404 Participants • One subject in the ART-123 arm and one in the Placebo arm did not have baseline height recorded in the eCRF	167.71 cm STANDARD_DEVIATION 9.190 • n=798 Participants • One subject in the ART-123 arm and one in the Placebo arm did not have baseline height recorded in the eCRF
Weight	75.01 kg STANDARD_DEVIATION 19.131 • n=394 Participants • One subject in the ART-123 arm did not have baseline weight recorded in the eCRF	75.74 kg STANDARD_DEVIATION 19.266 • n=405 Participants • One subject in the ART-123 arm did not have baseline weight recorded in the eCRF	75.38 kg STANDARD_DEVIATION 19.191 • n=799 Participants • One subject in the ART-123 arm did not have baseline weight recorded in the eCRF
APACHE II (mean, SD)	22.34 Total Score STANDARD_DEVIATION 8.071 • n=356 Participants • Subjects in the ART-123 and Placebo arms did not have baseline Apache II recorded in the eCRF	22.10 Total Score STANDARD_DEVIATION 8.025 • n=366 Participants • Subjects in the ART-123 and Placebo arms did not have baseline Apache II recorded in the eCRF	22.22 Total Score STANDARD_DEVIATION 8.043 • n=722 Participants • Subjects in the ART-123 and Placebo arms did not have baseline Apache II recorded in the eCRF
Arterial Lactate >55mg/dl (mean, SD)	53 Participants n=253 Participants • Subjects in the ART-123 and Placebo arms did not have baseline Arterial Lactate recorded in the eCRF	52 Participants n=279 Participants • Subjects in the ART-123 and Placebo arms did not have baseline Arterial Lactate recorded in the eCRF	105 Participants n=532 Participants • Subjects in the ART-123 and Placebo arms did not have baseline Arterial Lactate recorded in the eCRF

PRIMARY outcome

Timeframe: 28 days

Population: Full Analysis Set - All randomized and dosed subjects.

28-Day All-cause Mortality

Outcome measures

Measure	ART-123 n=395 Participants ART-123 (human recombinant thrombomodulin, thrombomodulin alfa) Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days	Placebo n=405 Participants Placebo Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
Number of Participants With 28-Day All-cause Mortality	106 Participants	119 Participants

PRIMARY outcome

Timeframe: Through Study Day 28

Population: Safety population: all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group)

On-treatment Serious Major Bleeding Events collected as Serious Adverse Events and defined as: any intracranial hemorrhage, any life-threatening bleeding, any bleeding event classified as serious by the Investigator (e.g., resulting in permanent morbidity), or any bleeding that required the administration of 1440 ml (typically 6 units) of packed red cells over two consecutive days. (Investigator assessment for seriousness criteria.)

Outcome measures

Measure	ART-123 n=396 Participants ART-123 (human recombinant thrombomodulin, thrombomodulin alfa) Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days	Placebo n=404 Participants Placebo Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
Number of Participants With On-Treatment Serious Major Bleeding Events	23 Participants	16 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Full Analysis Set - All randomized and dosed subjects.

Follow up all-cause mortality at 3 months

Outcome measures

Measure	ART-123 n=395 Participants ART-123 (human recombinant thrombomodulin, thrombomodulin alfa) Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days	Placebo n=405 Participants Placebo Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
Follow up All-cause Mortality at 3 Months	126 Participants	136 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Full Analysis Set - All randomized and dosed subjects.

Resolution of organ dysfunction as measured through day 28 by shock free, ventilator free, dialysis free plus alive days.

Outcome measures

Measure	ART-123 n=395 Participants ART-123 (human recombinant thrombomodulin, thrombomodulin alfa) Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days	Placebo n=405 Participants Placebo Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction Shock-free and alive	17.6 Days Standard Deviation 10.50	17.6 Days Standard Deviation 10.56
Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction Ventilation-free and alive	15.8 Days Standard Deviation 11.75	14.5 Days Standard Deviation 11.90
Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction Dialysis-free and alive	20.2 Days Standard Deviation 11.05	19.6 Days Standard Deviation 11.21

SECONDARY outcome

Timeframe: 18 months

Population: Safety population: all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group)

Presence of Anti-drug antibodies up to 18 months

Outcome measures

Measure	ART-123 n=396 Participants ART-123 (human recombinant thrombomodulin, thrombomodulin alfa) Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days	Placebo n=404 Participants Placebo Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
Number of Participants With Anti-drug Antibodies	0 Participants	0 Participants

POST_HOC outcome

Timeframe: Day 28

Population: Full Analysis Set - All randomized and dosed subjects.

Post-Hoc analysis of Day 28 Mortality in Subjects with INR > 1.4 at Baseline and PLT > 30K at Baseline

Outcome measures

Measure	ART-123 n=307 Participants ART-123 (human recombinant thrombomodulin, thrombomodulin alfa) Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days	Placebo n=327 Participants Placebo Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
Day 28 Mortality in Subjects With INR > 1.4 at Baseline and PLT > 30K at Baseline	82 Participants	105 Participants

Adverse Events

ART-123

Serious events: 206 serious events

Other events: 271 other events

Deaths: 141 deaths

Placebo

Serious events: 202 serious events

Other events: 264 other events

Deaths: 148 deaths

Serious adverse events

Measure	ART-123 n=396 participants at risk ART-123 (human recombinant thrombomodulin, thrombomodulin alfa) Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days	Placebo n=404 participants at risk Placebo Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
Infections and infestations Infectious pleural effusion	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Septic shock	7.1% 28/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	7.4% 30/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Sepsis	2.0% 8/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	2.7% 11/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Pneumonia	2.0% 8/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	2.5% 10/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Peritonitis	0.76% 3/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.74% 3/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Gangrene	0.76% 3/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Necrotising fasciitis	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.74% 3/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Endocarditis	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Endocarditis bacterial	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Abdominal sepsis	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Abdominal wall abscess	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Abscess limb	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Bacteraemia	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Catheter site infection	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Cellulitis	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Cellulitis gangrenous	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Fungal sepsis	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Haematoma infection	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Hepatic infection	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Herpes simplex pneumonia	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Infection	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Infective aneurysm	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Influenza	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Liver abscess	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Lung infection	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Pneumococcal sepsis	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Pneumonia fungal	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Pneumonia staphylococcal	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Postoperative wound infection	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Renal abscess	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Septic embolus	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Staphylococcal infection	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Staphylococcal sepsis	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Systemic candida	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Tracheobronchitis	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Varicella zoster pneumonia	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.8% 11/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	3.5% 14/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	2.0% 8/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	2.2% 9/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.3% 5/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.74% 3/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.99% 4/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.74% 3/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Diaphragm muscle weakness	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary haematoma	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory tract oedema	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Cardiac arrest	2.5% 10/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	2.7% 11/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Atrial fibrillation	1.5% 6/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	1.2% 5/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Bradycardia	1.0% 4/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Cardiac failure acute	1.0% 4/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Cardiopulmonary failure	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.74% 3/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Myocardial infarction	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.74% 3/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Cardio-respiratory arrest	0.76% 3/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Ventricular tachycardia	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Arrhythmia	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Cardiac failure	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Cardiogenic shock	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Supraventricular tachycardia	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Acute coronary syndrome	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Acute myocardial infarction	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Aortic valve incompetence	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Atrial flutter	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Atrial tachycardia	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Cardiac failure congestive	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Congestive cardiomyopathy	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Coronary artery stenosis	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Intracardiac thrombus	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Myocarditis	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Pericarditis	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Pulseless electrical activity	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
General disorders Multiple organ dysfunction syndrome	6.1% 24/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	6.9% 28/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
General disorders Death	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
General disorders Pyrexia	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
General disorders Catheter site haematoma	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
General disorders Catheter site haemorrhage	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
General disorders Organ failure	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Intestinal ischaemia	1.8% 7/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	1.5% 6/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	1.2% 5/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Gastrointestinal necrosis	0.76% 3/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Intestinal perforation	0.76% 3/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Large intestine perforation	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Abdominal pain	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Abdominal hernia	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Constipation	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Diarrhoea	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Fistula of small intestine	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Gastrointestinal perforation	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Gastrointestinal ulcer haemorrhage	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Gastrointestinal wall abnormal	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Hernial eventration	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Intestinal haemorrhage	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Intra-abdominal haematoma	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Mesenteric artery thrombosis	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Mesenteric haemorrhage	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Mesenteric vein thrombosis	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Mouth haemorrhage	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Oesophageal haemorrhage	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Pancreatic haemorrhage	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Retroperitoneal haematoma	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Thrombosis mesenteric vessel	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Vascular disorders Extremity necrosis	1.5% 6/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	1.5% 6/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Vascular disorders Shock	1.0% 4/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	1.7% 7/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Vascular disorders Deep vein thrombosis	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.99% 4/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Vascular disorders Shock haemorrhagic	1.5% 6/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Vascular disorders Hypotension	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Vascular disorders Arterial occlusive disease	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Vascular disorders Peripheral ischaemia	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Vascular disorders Aortic thrombosis	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Vascular disorders Arterial haemorrhage	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Vascular disorders Arterial thrombosis	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Vascular disorders Circulatory collapse	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Vascular disorders Haemorrhage	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Vascular disorders Peripheral coldness	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Vascular disorders Venous thrombosis limb	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Renal and urinary disorders Acute kidney injury	3.5% 14/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	2.5% 10/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Renal and urinary disorders Renal failure	0.76% 3/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Renal and urinary disorders Renal impairment	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Renal and urinary disorders Anuria	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Renal and urinary disorders Haematuria	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Renal and urinary disorders Renal ischaemia	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Blood and lymphatic system disorders Thrombocytopenia	2.5% 10/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	3.0% 12/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Blood and lymphatic system disorders Anaemia	1.3% 5/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	1.7% 7/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Blood and lymphatic system disorders Eosinophilia	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Blood and lymphatic system disorders Haemolysis	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Injury, poisoning and procedural complications Post procedural haemorrhage	1.5% 6/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Injury, poisoning and procedural complications Overdose	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.99% 4/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Injury, poisoning and procedural complications Anastomotic leak	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Injury, poisoning and procedural complications Wound haemorrhage	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Injury, poisoning and procedural complications Subdural haematoma	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Injury, poisoning and procedural complications Wound dehiscence	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Injury, poisoning and procedural complications Ankle fracture	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Injury, poisoning and procedural complications Chemical peritonitis	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Injury, poisoning and procedural complications Endotracheal intubation complication	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Injury, poisoning and procedural complications Femur fracture	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Injury, poisoning and procedural complications Intestinal anastomosis complication	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Injury, poisoning and procedural complications Post procedural haematoma	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Injury, poisoning and procedural complications Procedural haemorrhage	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Ischaemic stroke	1.0% 4/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Cerebral infarction	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Embolic cerebral infarction	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Cerebral haemorrhage	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Cerebrovascular accident	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Epilepsy	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Intensive care unit acquired weakness	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Brain hypoxia	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Brain injury	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Brain oedema	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Brain stem ischaemia	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Cerebral atrophy	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Cerebral haematoma	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Facial paralysis	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Haemorrhage intracranial	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Hypercapnic coma	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Paraplegia	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Polyneuropathy	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Posterior reversible encephalopathy syndrome	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Seizure	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Nervous system disorders Syncope	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Hepatobiliary disorders Hepatic function abnormal	0.76% 3/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.50% 2/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Hepatobiliary disorders Ischaemic hepatitis	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.74% 3/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Hepatobiliary disorders Hepatocellular injury	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Hepatobiliary disorders Acute hepatic failure	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Hepatobiliary disorders Hepatic failure	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Hepatobiliary disorders Hepatic necrosis	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Investigations Platelet count decreased	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Investigations Coma scale abnormal	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Investigations Glutamate dehydrogenase increased	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Investigations Haemoglobin decreased	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Investigations Hepatic enzyme abnormal	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Investigations Hepatic enzyme increased	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Investigations International normalised ratio abnormal	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Investigations Oxygen saturation decreased	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Electrolyte imbalance	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Hyperkalaemia	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Malnutrition	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	0.51% 2/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Ear and labyrinth disorders Deafness bilateral	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Endocrine disorders Adrenal haemorrhage	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Psychiatric disorders Delirium	0.25% 1/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.00% 0/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Reproductive system and breast disorders Pelvic fluid collection	0.00% 0/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	0.25% 1/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.

Other adverse events

Measure	ART-123 n=396 participants at risk ART-123 (human recombinant thrombomodulin, thrombomodulin alfa) Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days	Placebo n=404 participants at risk Placebo Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
Blood and lymphatic system disorders Anaemia	25.0% 99/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	19.3% 78/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Blood and lymphatic system disorders Thrombocytopenia	10.1% 40/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	12.6% 51/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Cardiac disorders Atrial fibrillation	12.9% 51/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	12.9% 52/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Constipation	9.3% 37/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	9.2% 37/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Diarrhoea	7.8% 31/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	8.9% 36/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Gastrointestinal disorders Nausea	7.8% 31/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	4.5% 18/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
General disorders Pyrexia	9.8% 39/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	8.2% 33/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
General disorders Oedema peripheral	5.1% 20/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	4.2% 17/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Infections and infestations Pneumonia	5.3% 21/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	5.4% 22/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Hypokalaemia	21.0% 83/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	17.1% 69/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Hypophosphataemia	11.6% 46/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	9.7% 39/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Hyperglycaemia	9.3% 37/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	8.4% 34/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Hypoglycaemia	6.3% 25/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	7.7% 31/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Hyperkalaemia	6.3% 25/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	5.0% 20/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	6.3% 25/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	4.7% 19/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Hypernatraemia	5.3% 21/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	5.4% 22/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Fluid overload	5.3% 21/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	4.0% 16/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Metabolism and nutrition disorders Hypocalcaemia	5.3% 21/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	2.7% 11/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Psychiatric disorders Delirium	7.8% 31/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	5.2% 21/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Psychiatric disorders Insomnia	5.1% 20/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	5.2% 21/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Renal and urinary disorders Acute kidney injury	7.1% 28/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	3.2% 13/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.8% 27/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	7.7% 31/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Vascular disorders Hypertension	5.8% 23/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	6.2% 25/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.
Vascular disorders Hypotension	5.8% 23/396 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.	5.9% 24/404 • Adverse events were collected between randomization and through Day 28 only. SAEs were collected from the time of authorization to randomize the participants until Day 28. All-cause mortality were collected as Fatal SAEs between randomization and Day 28 (End of Study) and as survival follow-up from Day 28 until 12 months. AEs were analyzed using a safety population that includes all subjects who received at least 1 dose of study drug (analyzed according to study drug received; any subjects receiving both ART-123 and placebo were to be included in the ART-123 group). Treatment Emergent Serious Adverse Events (TESAE) were analyzed by System Organ Class and Preferred Term. A treatment-emergent adverse event (TEAE) is defined as any AE following exposure to study treatment.

Additional Information

Director of Clinical Operations

Asahi Kasei Pharma America Corp.

Phone: (781) 419-1919

Email: pallton@akpamerica.com

Results disclosure agreements

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

Restriction type: LTE60