Trial Outcomes & Findings for A Randomized Phase 2/3 Multi-Center Study of SM-88 in Participants With Metastatic Pancreatic Cancer (NCT NCT03512756)

NCT ID: NCT03512756

Last Updated: 2024-11-06

Results Overview

OS was defined as the number of days between the first study drug administration and death from any cause. Results are reported in weeks.

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 130 participants
• Primary outcome timeframe: Up to 12 months
• Results posted on: 2024-11-06

Participant Flow

This was a two-part study. The first part (Part 1) was used to determine which dose of SM-88 was to be selected for further study (recommended for Phase 2 dose [RP2D]). The second part (Part 2) consisted of an expansion cohort of participants at the selected dose of Physician's Choice therapies.

Participant milestones

Measure	Part 1: SM-88 460 Milligrams (mg) Participants received 230 mg SM-88 oral tablets twice daily along with methoxsalen, phenytoin, and sirolimus (MPS) for up to 6 months	Part 1: SM-88 920 mg Participants received 460 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 2: SM-88 920 mg Participants received 460 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 2: Physician's Choice Participants received one of capecitabine, gemcitabine or 5-fluorouracil (FU) per the physician's choice
Part 1 STARTED	25	24	0	0
Part 1 Received At Least 1 Dose of Study Drug	25	23	0	0
Part 1 COMPLETED	0	0	0	0
Part 1 NOT COMPLETED	25	24	0	0
Part 2 STARTED	0	0	41	40
Part 2 Received At Least 1 Dose of Study Drug	0	0	40	30
Part 2 COMPLETED	0	0	0	0
Part 2 NOT COMPLETED	0	0	41	40

Reasons for withdrawal

Measure	Part 1: SM-88 460 Milligrams (mg) Participants received 230 mg SM-88 oral tablets twice daily along with methoxsalen, phenytoin, and sirolimus (MPS) for up to 6 months	Part 1: SM-88 920 mg Participants received 460 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 2: SM-88 920 mg Participants received 460 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 2: Physician's Choice Participants received one of capecitabine, gemcitabine or 5-fluorouracil (FU) per the physician's choice
Part 1 Death	23	18	0	0
Part 1 Lost to Follow-up	0	3	0	0
Part 1 Physician Decision	0	1	0	0
Part 1 Withdrawal by Subject	2	2	0	0
Part 2 Death	0	0	32	21
Part 2 Lost to Follow-up	0	0	1	0
Part 2 Physician Decision	0	0	2	4
Part 2 Study Terminated by Sponsor	0	0	2	6
Part 2 Protocol Violation	0	0	1	0
Part 2 Withdrawal by Subject	0	0	3	9

Baseline Characteristics

A Randomized Phase 2/3 Multi-Center Study of SM-88 in Participants With Metastatic Pancreatic Cancer

Baseline characteristics by cohort

Measure	Part 1: SM-88 460 mg n=25 Participants Participants received 230 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 1: SM-88 920 mg n=23 Participants Participants received 460 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 2: SM-88 920 mg n=40 Participants Participants received 460 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 2: Physician's Choice n=30 Participants Participants received one of capecitabine, gemcitabine or 5-FU per the physician's choice	Total n=118 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants	7 Participants n=4 Participants	51 Participants n=21 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants	23 Participants n=4 Participants	67 Participants n=21 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants	13 Participants n=4 Participants	50 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants	17 Participants n=4 Participants	68 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	23 Participants n=7 Participants	33 Participants n=5 Participants	29 Participants n=4 Participants	109 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	21 Participants n=7 Participants	33 Participants n=5 Participants	19 Participants n=4 Participants	98 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Population: Evaluable Population included all participants enrolled in the study who received at least 1 cycle (28 days) of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this Outcome Measure.

OS was defined as the number of days between the first study drug administration and death from any cause. Results are reported in weeks.

Outcome measures

Measure	Part 1: SM-88 460 mg n=20 Participants Participants received 230 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 1: SM-88 920 mg n=17 Participants Participants received 460 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 2: SM-88 920 mg n=33 Participants Participants received 460 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 2: Physician's Choice n=27 Participants Participants received one of capecitabine, gemcitabine or 5-FU per the physician's choice
Overall Survival (OS)	21.3 Weeks Interval 9.7 to 35.0	15.7 Weeks Interval 11.1 to 24.7	14.0 Weeks Interval 11.1 to 19.4	24.1 Weeks Interval 13.7 to 31.6

SECONDARY outcome

Timeframe: Up to 12 months

Population: Intent to Treat (ITT) Population included all participants who consented in the study and randomized to treatment, and assigned to treatment they were randomized to. Here, 'Overall number of participants analyzed' = participants evaluable for this Outcome Measure.

Progression-Free Survival (PFS), is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Results are reported in weeks.

Outcome measures

Measure	Part 1: SM-88 460 mg n=25 Participants Participants received 230 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 1: SM-88 920 mg n=24 Participants Participants received 460 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 2: SM-88 920 mg n=41 Participants Participants received 460 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 2: Physician's Choice n=40 Participants Participants received one of capecitabine, gemcitabine or 5-FU per the physician's choice
Progression Free Survival (PFS)	8.0 Weeks Interval 7.1 to 8.6	8.0 Weeks Interval 5.6 to 11.1	7.7 Weeks Interval 5.6 to 8.0	8.9 Weeks Interval 6.0 to 12.7

Adverse Events

Part 1: SM-88 460 mg

Serious events: 14 serious events

Other events: 12 other events

Deaths: 23 deaths

Part 1: SM-88 920 mg

Serious events: 12 serious events

Other events: 10 other events

Deaths: 18 deaths

Part 2: SM-88 920 mg

Serious events: 19 serious events

Other events: 23 other events

Deaths: 32 deaths

Part 2: Physician's Choice

Serious events: 11 serious events

Other events: 18 other events

Deaths: 21 deaths

Serious adverse events

Measure	Part 1: SM-88 460 mg n=25 participants at risk Participants received 230 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 1: SM-88 920 mg n=23 participants at risk Participants received 460 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 2: SM-88 920 mg n=40 participants at risk Participants received 460 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 2: Physician's Choice n=30 participants at risk Participants received one of capecitabine, gemcitabine or 5-FU per the physician's choice
Cardiac disorders Angina pectoris	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Cardiac disorders Cardiac failure	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Gastrointestinal disorders Abdominal pain	8.0% 2/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	21.7% 5/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Gastrointestinal disorders Ascites	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Gastrointestinal disorders Constipation	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Gastrointestinal disorders Dysphagia	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Gastrointestinal disorders Nausea	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	6.7% 2/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Gastrointestinal disorders Vomiting	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
General disorders Death	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
General disorders Pyrexia	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	7.5% 3/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Hepatobiliary disorders Bile duct obstruction	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Hepatobiliary disorders Cholangitis	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	8.7% 2/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Infections and infestations Corona virus infection	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Infections and infestations Endocarditis	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Infections and infestations Enterobacter sepsis	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Infections and infestations Klebsiella bacteraemia	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Infections and infestations Peritonitis bacterial	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Infections and infestations Sepsis	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	8.7% 2/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Injury, poisoning and procedural complications Afferent loop syndrome	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Injury, poisoning and procedural complications Femoral neck fracture	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Investigations Blood bilirubin increased	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	5.0% 2/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Investigations Haemoglobin decreased	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Metabolism and nutrition disorders Dehydration	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Metabolism and nutrition disorders Hyperglycaemia	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Nervous system disorders Ischaemic stroke	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Nervous system disorders Metabolic encephalopathy	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Nervous system disorders Transient ischaemic attack	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Psychiatric disorders Mental status changes	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Renal and urinary disorders Acute kidney injury	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Respiratory, thoracic and mediastinal disorders Haemoptysis	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.0% 3/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	8.0% 2/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Vascular disorders Embolism	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Vascular disorders Hypotension	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.

Other adverse events

Measure	Part 1: SM-88 460 mg n=25 participants at risk Participants received 230 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 1: SM-88 920 mg n=23 participants at risk Participants received 460 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 2: SM-88 920 mg n=40 participants at risk Participants received 460 mg SM-88 oral tablets twice daily along with MPS for up to 6 months	Part 2: Physician's Choice n=30 participants at risk Participants received one of capecitabine, gemcitabine or 5-FU per the physician's choice
Investigations Blood alkaline phosphatase increased	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	7.5% 3/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Blood and lymphatic system disorders Anaemia	8.0% 2/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	13.0% 3/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	7.5% 3/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	10.0% 3/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Blood and lymphatic system disorders Neutropenia	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Gastrointestinal disorders Abdominal pain	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Gastrointestinal disorders Ascites	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	6.7% 2/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Gastrointestinal disorders Diarrhoea	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Gastrointestinal disorders Nausea	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Gastrointestinal disorders Obstruction gastric	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
General disorders Asthenia	8.0% 2/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
General disorders Fatigue	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	10.0% 4/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
General disorders Oedema	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Hepatobiliary disorders Bile duct obstruction	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Infections and infestations Bacteraemia	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Infections and infestations Pneumonia	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Infections and infestations Systemic candida	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Investigations Alanine aminotransferase increased	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Investigations Aspartate aminotransferase increased	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Investigations Blood bilirubin increased	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	10.0% 3/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Investigations Lymphocyte count decreased	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	6.7% 2/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Investigations Neutrophil count decreased	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Investigations Weight increased	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Investigations White blood cell count decreased	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Metabolism and nutrition disorders Dehydration	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	5.0% 2/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Metabolism and nutrition disorders Hypokalaemia	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Metabolism and nutrition disorders Hyponatraemia	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	8.7% 2/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Metabolism and nutrition disorders Malnutrition	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Musculoskeletal and connective tissue disorders Arthralgia	8.0% 2/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Musculoskeletal and connective tissue disorders Back pain	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Musculoskeletal and connective tissue disorders Depression	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Musculoskeletal and connective tissue disorders Embolic stroke	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	2.5% 1/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Vascular disorders Deep vein thrombosis	4.0% 1/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Vascular disorders Embolism	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	3.3% 1/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Vascular disorders Hypertension	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.
Vascular disorders Hypotension	0.00% 0/25 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	4.3% 1/23 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/40 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.	0.00% 0/30 • All-Cause Mortality are reported from participant randomization up to 12 months. Serious and Other Adverse Events are reported from the date of first dose to 28 days after the date of last dose (up to 12 months) All-cause mortality was assessed in all enrolled participants. Safety Analysis Population was used to report Serious and Other Adverse Events. It included all participants enrolled in the study who received at least one dose of study drug, and assigned to treatment actually received.

Additional Information

Study Director

Tyme, Inc.

Phone: 617-674-9069

Email: Maria.Loushin@TymeInc.com

Results disclosure agreements

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