Trial Outcomes & Findings for (Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI (NCT NCT04411472)

NCT ID: NCT04411472

Last Updated: 2024-06-03

Results Overview

To demonstrate an effect of recAP on 28 day all cause mortality

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 676 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2024-06-03

Participant Flow

The target participant population consisted of adult participants in the intensive care unit or intermediate care unit with sepsis and new, recent onset acute kidney injury.

676 participants were enrolled; 21 were screening failures and were not randomized. 5 participants (2 in the active group and 3 in the placebo group) were randomized, but not been exposed to any trial drug. Consequently, 650 patients have been randomized and treated (modified ITT population according to protocol). The mITT population is the basis for the primary efficacy analysis and most of the secondary analyses reported in clintrials.gov (1-6,8-16).

Participant milestones

Measure	Placebo (Main Trial Population) Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3. Main Trial Population: Participants with a pre-AKI reference eGFR greater than or equal to 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	recAP 1.6 mg/kg (Main Trial Population) Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 Main Trial Population: Participants with a pre-AKI reference eGFR greater than or equal to 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	Placebo (Moderate CKD Population) Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3. Moderate chronic kidney disease (CKD) Population: Participants with a pre-acute kidney injury reference estimated glomerular filtration rate more than or equal to 25 and less than 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	recAP 1.6 mg/kg (Moderate CKD Population) Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 Moderate chronic kidney disease (CKD) Population: Participants with a pre-acute kidney injury reference estimated glomerular filtration rate more than or equal to 25 and less than 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	Placebo (COVID-19 Population) Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3. COVID-19 Population: Participants with proven or suspected COVID-19 at time of randomization with or without 'moderate' chronic kidney disease and, for patients in this population, COVID-19 should have been the main cause of sepsis-associated acute kidney injury	recAP 1.6 mg/kg (COVID-19 Population) Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 COVID-19 Population: Participants with proven or suspected COVID-19 at time of randomization with or without 'moderate' chronic kidney disease and, for patients in this population, COVID-19 should have been the main cause of sepsis-associated acute kidney injury
Overall Study STARTED	277	279	31	30	13	20
Overall Study COMPLETED	253	248	27	29	13	20
Overall Study NOT COMPLETED	24	31	4	1	0	0

Reasons for withdrawal

Measure	Placebo (Main Trial Population) Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3. Main Trial Population: Participants with a pre-AKI reference eGFR greater than or equal to 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	recAP 1.6 mg/kg (Main Trial Population) Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 Main Trial Population: Participants with a pre-AKI reference eGFR greater than or equal to 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	Placebo (Moderate CKD Population) Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3. Moderate chronic kidney disease (CKD) Population: Participants with a pre-acute kidney injury reference estimated glomerular filtration rate more than or equal to 25 and less than 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	recAP 1.6 mg/kg (Moderate CKD Population) Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 Moderate chronic kidney disease (CKD) Population: Participants with a pre-acute kidney injury reference estimated glomerular filtration rate more than or equal to 25 and less than 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	Placebo (COVID-19 Population) Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3. COVID-19 Population: Participants with proven or suspected COVID-19 at time of randomization with or without 'moderate' chronic kidney disease and, for patients in this population, COVID-19 should have been the main cause of sepsis-associated acute kidney injury	recAP 1.6 mg/kg (COVID-19 Population) Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 COVID-19 Population: Participants with proven or suspected COVID-19 at time of randomization with or without 'moderate' chronic kidney disease and, for patients in this population, COVID-19 should have been the main cause of sepsis-associated acute kidney injury
Overall Study Adverse Event	5	10	1	0	0	0
Overall Study Protocol Violation	1	0	0	0	0	0
Overall Study Withdrawal by Subject	0	1	0	1	0	0
Overall Study Physician Decision	1	0	0	0	0	0
Overall Study Study terminated by sponsor	17	20	3	0	0	0

Baseline Characteristics

The height and weight information was missing for one participant in the placebo group.

Baseline characteristics by cohort

Measure	Placebo (Main Trial Population) n=277 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 Main Trial Population: Participants with a pre-AKI reference eGFR greater than or equal to 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	recAP 1.6 mg/kg (Main Trial Population) n=279 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 Main Trial Population: Participants with a pre-AKI reference eGFR greater than or equal to 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	Placebo (Moderate CKD Population) n=31 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3. Moderate chronic kidney disease (CKD) Population: Participants with a pre-acute kidney injury reference estimated glomerular filtration rate more than or equal to 25 and less than 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	recAP 1.6 mg/kg (Moderate CKD Population) n=30 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 Moderate chronic kidney disease (CKD) Population: Participants with a pre-acute kidney injury reference estimated glomerular filtration rate more than or equal to 25 and less than 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	Placebo (COVID-19 Population) n=13 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3. COVID-19 Population: Participants with proven or suspected COVID-19 at time of randomization with or without 'moderate' chronic kidney disease and, for patients in this population, COVID-19 should have been the main cause of sepsis-associated acute kidney injury	recAP 1.6 mg/kg (COVID-19 Population) n=20 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 COVID-19 Population: Participants with proven or suspected COVID-19 at time of randomization with or without 'moderate' chronic kidney disease and, for patients in this population, COVID-19 should have been the main cause of sepsis-associated acute kidney injury	Total n=650 Participants Total of all reporting groups
Age, Continuous	67.1 years STANDARD_DEVIATION 12.73 • n=277 Participants	68.4 years STANDARD_DEVIATION 10.94 • n=279 Participants	73.2 years STANDARD_DEVIATION 8.90 • n=31 Participants	70.2 years STANDARD_DEVIATION 11.28 • n=30 Participants	68.8 years STANDARD_DEVIATION 7.67 • n=13 Participants	62.8 years STANDARD_DEVIATION 10.35 • n=20 Participants	68.0 years STANDARD_DEVIATION 11.69 • n=650 Participants
Sex: Female, Male Female	104 Participants n=277 Participants	105 Participants n=279 Participants	8 Participants n=31 Participants	12 Participants n=30 Participants	2 Participants n=13 Participants	6 Participants n=20 Participants	237 Participants n=650 Participants
Sex: Female, Male Male	173 Participants n=277 Participants	174 Participants n=279 Participants	23 Participants n=31 Participants	18 Participants n=30 Participants	11 Participants n=13 Participants	14 Participants n=20 Participants	413 Participants n=650 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=277 Participants	1 Participants n=279 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=13 Participants	0 Participants n=20 Participants	1 Participants n=650 Participants
Race (NIH/OMB) Asian	23 Participants n=277 Participants	16 Participants n=279 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	1 Participants n=13 Participants	1 Participants n=20 Participants	41 Participants n=650 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=277 Participants	0 Participants n=279 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=13 Participants	0 Participants n=20 Participants	0 Participants n=650 Participants
Race (NIH/OMB) Black or African American	9 Participants n=277 Participants	6 Participants n=279 Participants	0 Participants n=31 Participants	1 Participants n=30 Participants	0 Participants n=13 Participants	3 Participants n=20 Participants	19 Participants n=650 Participants
Race (NIH/OMB) White	227 Participants n=277 Participants	233 Participants n=279 Participants	27 Participants n=31 Participants	26 Participants n=30 Participants	11 Participants n=13 Participants	15 Participants n=20 Participants	539 Participants n=650 Participants
Race (NIH/OMB) More than one race	0 Participants n=277 Participants	1 Participants n=279 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=13 Participants	0 Participants n=20 Participants	1 Participants n=650 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=277 Participants	22 Participants n=279 Participants	4 Participants n=31 Participants	3 Participants n=30 Participants	1 Participants n=13 Participants	1 Participants n=20 Participants	49 Participants n=650 Participants
Height	170.4 centimeters STANDARD_DEVIATION 10.20 • n=276 Participants • The height and weight information was missing for one participant in the placebo group.	170.5 centimeters STANDARD_DEVIATION 10.30 • n=279 Participants • The height and weight information was missing for one participant in the placebo group.	171.2 centimeters STANDARD_DEVIATION 8.84 • n=31 Participants • The height and weight information was missing for one participant in the placebo group.	171.8 centimeters STANDARD_DEVIATION 8.98 • n=30 Participants • The height and weight information was missing for one participant in the placebo group.	170.0 centimeters STANDARD_DEVIATION 10.13 • n=13 Participants • The height and weight information was missing for one participant in the placebo group.	174.3 centimeters STANDARD_DEVIATION 10.06 • n=20 Participants • The height and weight information was missing for one participant in the placebo group.	170.7 centimeters STANDARD_DEVIATION 10.12 • n=649 Participants • The height and weight information was missing for one participant in the placebo group.
Weight	86.9 kilograms STANDARD_DEVIATION 26.23 • n=276 Participants • The height and weight information was missing for one participant in the placebo group.	87.9 kilograms STANDARD_DEVIATION 25.67 • n=279 Participants • The height and weight information was missing for one participant in the placebo group.	87.3 kilograms STANDARD_DEVIATION 17.08 • n=31 Participants • The height and weight information was missing for one participant in the placebo group.	86.5 kilograms STANDARD_DEVIATION 16.94 • n=30 Participants • The height and weight information was missing for one participant in the placebo group.	98.9 kilograms STANDARD_DEVIATION 26.67 • n=13 Participants • The height and weight information was missing for one participant in the placebo group.	87.1 kilograms STANDARD_DEVIATION 19.39 • n=20 Participants • The height and weight information was missing for one participant in the placebo group.	87.6 kilograms STANDARD_DEVIATION 25.06 • n=649 Participants • The height and weight information was missing for one participant in the placebo group.
Acute Physiology and Chronic Health Evaluation II total score	23.2 score STANDARD_DEVIATION 7.17 • n=267 Participants • The score was not recorded for 25 participants. This included 10 participants in the placebo group (main trial population), 13 participants in the recAP 1.6 mg/kg group (main trial population), 1 participant in the recAP 1.6 mg/kg group (moderate CKD population), and 1 participant in the recAP 1.6 mg/kg group (COVID-19 population).	23.2 score STANDARD_DEVIATION 7.65 • n=266 Participants • The score was not recorded for 25 participants. This included 10 participants in the placebo group (main trial population), 13 participants in the recAP 1.6 mg/kg group (main trial population), 1 participant in the recAP 1.6 mg/kg group (moderate CKD population), and 1 participant in the recAP 1.6 mg/kg group (COVID-19 population).	25.8 score STANDARD_DEVIATION 7.00 • n=31 Participants • The score was not recorded for 25 participants. This included 10 participants in the placebo group (main trial population), 13 participants in the recAP 1.6 mg/kg group (main trial population), 1 participant in the recAP 1.6 mg/kg group (moderate CKD population), and 1 participant in the recAP 1.6 mg/kg group (COVID-19 population).	23.6 score STANDARD_DEVIATION 5.77 • n=29 Participants • The score was not recorded for 25 participants. This included 10 participants in the placebo group (main trial population), 13 participants in the recAP 1.6 mg/kg group (main trial population), 1 participant in the recAP 1.6 mg/kg group (moderate CKD population), and 1 participant in the recAP 1.6 mg/kg group (COVID-19 population).	23.1 score STANDARD_DEVIATION 6.87 • n=13 Participants • The score was not recorded for 25 participants. This included 10 participants in the placebo group (main trial population), 13 participants in the recAP 1.6 mg/kg group (main trial population), 1 participant in the recAP 1.6 mg/kg group (moderate CKD population), and 1 participant in the recAP 1.6 mg/kg group (COVID-19 population).	23.6 score STANDARD_DEVIATION 8.31 • n=19 Participants • The score was not recorded for 25 participants. This included 10 participants in the placebo group (main trial population), 13 participants in the recAP 1.6 mg/kg group (main trial population), 1 participant in the recAP 1.6 mg/kg group (moderate CKD population), and 1 participant in the recAP 1.6 mg/kg group (COVID-19 population).	23.3 score STANDARD_DEVIATION 7.34 • n=625 Participants • The score was not recorded for 25 participants. This included 10 participants in the placebo group (main trial population), 13 participants in the recAP 1.6 mg/kg group (main trial population), 1 participant in the recAP 1.6 mg/kg group (moderate CKD population), and 1 participant in the recAP 1.6 mg/kg group (COVID-19 population).
Modified sequential organ failure assessment total score (eCRF)	9.4 score STANDARD_DEVIATION 2.52 • n=276 Participants • The score was not recorded for 1 participant in the placebo group and 3 participants in the recAP 1.6 mg/kg group (main trial population).	9.1 score STANDARD_DEVIATION 2.33 • n=276 Participants • The score was not recorded for 1 participant in the placebo group and 3 participants in the recAP 1.6 mg/kg group (main trial population).	9.5 score STANDARD_DEVIATION 1.46 • n=31 Participants • The score was not recorded for 1 participant in the placebo group and 3 participants in the recAP 1.6 mg/kg group (main trial population).	9.0 score STANDARD_DEVIATION 1.88 • n=30 Participants • The score was not recorded for 1 participant in the placebo group and 3 participants in the recAP 1.6 mg/kg group (main trial population).	9.4 score STANDARD_DEVIATION 1.66 • n=13 Participants • The score was not recorded for 1 participant in the placebo group and 3 participants in the recAP 1.6 mg/kg group (main trial population).	9.6 score STANDARD_DEVIATION 2.03 • n=20 Participants • The score was not recorded for 1 participant in the placebo group and 3 participants in the recAP 1.6 mg/kg group (main trial population).	9.3 score STANDARD_DEVIATION 2.34 • n=646 Participants • The score was not recorded for 1 participant in the placebo group and 3 participants in the recAP 1.6 mg/kg group (main trial population).
Pre-acute kidney injury reference creatinine	83.36 μmol/L STANDARD_DEVIATION 22.316 • n=276 Participants • The value was not recorded for 1 participant in the placebo group.	82.23 μmol/L STANDARD_DEVIATION 21.865 • n=279 Participants • The value was not recorded for 1 participant in the placebo group.	130.42 μmol/L STANDARD_DEVIATION 56.751 • n=31 Participants • The value was not recorded for 1 participant in the placebo group.	122.56 μmol/L STANDARD_DEVIATION 33.684 • n=30 Participants • The value was not recorded for 1 participant in the placebo group.	87.99 μmol/L STANDARD_DEVIATION 23.494 • n=13 Participants • The value was not recorded for 1 participant in the placebo group.	95.97 μmol/L STANDARD_DEVIATION 27.159 • n=20 Participants • The value was not recorded for 1 participant in the placebo group.	87.42 μmol/L STANDARD_DEVIATION 28.542 • n=649 Participants • The value was not recorded for 1 participant in the placebo group.
Pre-acute kidney injury reference estimated glomerular filtration rate	76.16 mL/min/1.73 m² STANDARD_DEVIATION 18.160 • n=276 Participants • The value was not recorded for 1 participant in the placebo group.	76.35 mL/min/1.73 m² STANDARD_DEVIATION 18.059 • n=279 Participants • The value was not recorded for 1 participant in the placebo group.	52.36 mL/min/1.73 m² STANDARD_DEVIATION 25.715 • n=31 Participants • The value was not recorded for 1 participant in the placebo group.	51.57 mL/min/1.73 m² STANDARD_DEVIATION 21.945 • n=30 Participants • The value was not recorded for 1 participant in the placebo group.	74.88 mL/min/1.73 m² STANDARD_DEVIATION 15.742 • n=13 Participants • The value was not recorded for 1 participant in the placebo group.	72.82 mL/min/1.73 m² STANDARD_DEVIATION 18.438 • n=20 Participants • The value was not recorded for 1 participant in the placebo group.	73.84 mL/min/1.73 m² STANDARD_DEVIATION 19.917 • n=649 Participants • The value was not recorded for 1 participant in the placebo group.
Acute kidney injury diagnosis creatinine	212.43 μmol/L STANDARD_DEVIATION 138.656 • n=276 Participants • The diagnosis was not recorded for 1 participant in the placebo group.	200.06 μmol/L STANDARD_DEVIATION 123.685 • n=279 Participants • The diagnosis was not recorded for 1 participant in the placebo group.	270.10 μmol/L STANDARD_DEVIATION 286.051 • n=31 Participants • The diagnosis was not recorded for 1 participant in the placebo group.	210.11 μmol/L STANDARD_DEVIATION 93.540 • n=30 Participants • The diagnosis was not recorded for 1 participant in the placebo group.	176.20 μmol/L STANDARD_DEVIATION 42.570 • n=13 Participants • The diagnosis was not recorded for 1 participant in the placebo group.	211.30 μmol/L STANDARD_DEVIATION 148.803 • n=20 Participants • The diagnosis was not recorded for 1 participant in the placebo group.	209.00 μmol/L STANDARD_DEVIATION 140.799 • n=649 Participants • The diagnosis was not recorded for 1 participant in the placebo group.
Acute kidney injury diagnosis estimated glomerular filtration rate	32.28 mL/min/1.73 m² STANDARD_DEVIATION 14.888 • n=276 Participants • The diagnosis was not recorded for 1 participant in the placebo group.	33.10 mL/min/1.73 m² STANDARD_DEVIATION 14.958 • n=279 Participants • The diagnosis was not recorded for 1 participant in the placebo group.	25.93 mL/min/1.73 m² STANDARD_DEVIATION 12.042 • n=31 Participants • The diagnosis was not recorded for 1 participant in the placebo group.	30.97 mL/min/1.73 m² STANDARD_DEVIATION 20.116 • n=30 Participants • The diagnosis was not recorded for 1 participant in the placebo group.	33.54 mL/min/1.73 m² STANDARD_DEVIATION 7.002 • n=13 Participants • The diagnosis was not recorded for 1 participant in the placebo group.	35.42 mL/min/1.73 m² STANDARD_DEVIATION 16.461 • n=20 Participants • The diagnosis was not recorded for 1 participant in the placebo group.	32.39 mL/min/1.73 m² STANDARD_DEVIATION 15.045 • n=649 Participants • The diagnosis was not recorded for 1 participant in the placebo group.
KDIGO Chronic Kidney Disease stage 1	67 Participants n=277 Participants	69 Participants n=279 Participants	4 Participants n=31 Participants	2 Participants n=30 Participants	3 Participants n=13 Participants	3 Participants n=20 Participants	148 Participants n=650 Participants
KDIGO Chronic Kidney Disease stage 2	152 Participants n=277 Participants	153 Participants n=279 Participants	6 Participants n=31 Participants	9 Participants n=30 Participants	8 Participants n=13 Participants	13 Participants n=20 Participants	341 Participants n=650 Participants
KDIGO Chronic Kidney Disease stage 3a	53 Participants n=277 Participants	50 Participants n=279 Participants	2 Participants n=31 Participants	0 Participants n=30 Participants	2 Participants n=13 Participants	3 Participants n=20 Participants	110 Participants n=650 Participants
KDIGO Chronic Kidney Disease stage 3b	3 Participants n=277 Participants	7 Participants n=279 Participants	15 Participants n=31 Participants	17 Participants n=30 Participants	0 Participants n=13 Participants	0 Participants n=20 Participants	42 Participants n=650 Participants
KDIGO Chronic Kidney Disease stage 4	1 Participants n=277 Participants	0 Participants n=279 Participants	3 Participants n=31 Participants	2 Participants n=30 Participants	0 Participants n=13 Participants	1 Participants n=20 Participants	7 Participants n=650 Participants
KDIGO Chronic Kidney Disease stage 5	0 Participants n=277 Participants	0 Participants n=279 Participants	1 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=13 Participants	0 Participants n=20 Participants	1 Participants n=650 Participants
KDIGO Chronic Kidney Disease stage Missing	1 Participants n=277 Participants	0 Participants n=279 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=13 Participants	0 Participants n=20 Participants	1 Participants n=650 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Main Trial modified intent-to-treat Population

To demonstrate an effect of recAP on 28 day all cause mortality

Outcome measures

Measure	Placebo n=277 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3	recAP 1.6 mg/kg n=279 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3
28-day All-cause Mortality: Main Trial Population Participants with known survival status at Day 28	272 Participants	279 Participants
28-day All-cause Mortality: Main Trial Population Number of participants died by Day 28	69 Participants	80 Participants
28-day All-cause Mortality: Main Trial Population Participants where survival status is unknown at Day 28	5 Participants	0 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Moderate Chronic Kidney Disease modified intent-to-treat Population

To demonstrate an effect of recAP on 28 day all cause mortality

Outcome measures

Measure	Placebo n=31 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3	recAP 1.6 mg/kg n=30 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3
28-day All-cause Mortality: Moderate Chronic Kidney Disease Population Participants with known survival status at Day 28	31 Participants	29 Participants
28-day All-cause Mortality: Moderate Chronic Kidney Disease Population Number of participants died by Day 28	10 Participants	6 Participants
28-day All-cause Mortality: Moderate Chronic Kidney Disease Population Participants where survival status is unknown at Day 28	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 28 days

Population: COVID-19 modified intent-to-treat Population

To demonstrate an effect of recAP on 28 day all cause mortality

Outcome measures

Measure	Placebo n=13 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3	recAP 1.6 mg/kg n=20 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3
28-day All-cause Mortality: COVID-19 Population Number of participants died by Day 28	11 Participants	5 Participants
28-day All-cause Mortality: COVID-19 Population Participants with known survival status at Day 28	13 Participants	20 Participants
28-day All-cause Mortality: COVID-19 Population Participants where survival status is unknown at Day 28	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 90 Days

Population: Main Trial modified intent-to-treat Population

Major adverse kidney events (MAKE) 90: dead by Day 90 or on Renal Replacement Therapy (RRT) at Day 90 or greater than or equal to 25% decline in estimated glomerular filtration rate (eGFR) on both Day 28 and Day 90 relative to the known or assumed pre-acute kidney injury reference level.

Outcome measures

Measure	Placebo n=277 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3	recAP 1.6 mg/kg n=279 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3
Major Adverse Kidney Events 90: Main Trial Population Participants with missing data on MAKE 90	36 Participants	49 Participants
Major Adverse Kidney Events 90: Main Trial Population Participants with unknown data on MAKE 90	46 Participants	34 Participants
Major Adverse Kidney Events 90: Main Trial Population MAKE 90: Dead	89 Participants	97 Participants
Major Adverse Kidney Events 90: Main Trial Population MAKE 90: On RRT	2 Participants	0 Participants
Major Adverse Kidney Events 90: Main Trial Population MAKE 90: greater than or equal to 25% decline in eGFR rate on both Day 28 and Day 90	15 Participants	7 Participants

SECONDARY outcome

Timeframe: 90 Days

Population: Moderate Chronic Kidney Disease modified intent-to-treat Population

Major adverse kidney events (MAKE) 90: dead by Day 90 or on Renal Replacement Therapy (RRT) at Day 90 or greater than or equal to 25% decline in estimated glomerular filtration rate (eGFR) on both Day 28 and Day 90 relative to the known or assumed pre-acute kidney injury reference level.

Outcome measures

Measure	Placebo n=31 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3	recAP 1.6 mg/kg n=30 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3
Major Adverse Kidney Events 90: Moderate Chronic Kidney Disease Population Participants with missing data on MAKE 90	7 Participants	7 Participants
Major Adverse Kidney Events 90: Moderate Chronic Kidney Disease Population Participants with unknown data on MAKE 90	2 Participants	6 Participants
Major Adverse Kidney Events 90: Moderate Chronic Kidney Disease Population MAKE 90: Dead	13 Participants	7 Participants
Major Adverse Kidney Events 90: Moderate Chronic Kidney Disease Population MAKE 90: On RRT	0 Participants	0 Participants
Major Adverse Kidney Events 90: Moderate Chronic Kidney Disease Population MAKE 90: greater than or equal to 25% decline in eGFR rate on both Day 28 and Day 90	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 90 Days

Population: COVID-19 modified intent-to-treat Population

Major adverse kidney events (MAKE) 90: dead by Day 90 or on Renal Replacement Therapy (RRT) at Day 90 or greater than or equal to 25% decline in estimated glomerular filtration rate (eGFR) on both Day 28 and Day 90 relative to the known or assumed pre-acute kidney injury reference level.

Outcome measures

Measure	Placebo n=13 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3	recAP 1.6 mg/kg n=20 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3
Major Adverse Kidney Events 90: COVID-19 Population Participants with missing data on MAKE 90	1 Participants	4 Participants
Major Adverse Kidney Events 90: COVID-19 Population Participants with unknown data on MAKE 90	0 Participants	0 Participants
Major Adverse Kidney Events 90: COVID-19 Population MAKE 90: Dead	11 Participants	6 Participants
Major Adverse Kidney Events 90: COVID-19 Population MAKE 90: On RRT	0 Participants	0 Participants
Major Adverse Kidney Events 90: COVID-19 Population MAKE 90: greater than or equal to 25% decline in eGFR rate on both Day 28 and Day 90	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 90 Days

Population: Combined population: From the 650 patients in the mITT population (321 Placebo and 329 recAP), 649 were analysed in the combined population (1 participant randomized and treated with placebo has been excluded as no efficacy data were available). In the combined population participants were analyzed as treated, resulting in 319 Placebo and 330 recAP participants (2 participants randomized to Placebo were treated with recAP, 1 participant randomized to recAP was treated with placebo).

Major Adverse Kidney Events through day 90 (MAKE90A) :

• death until day 90
• greater than 25% drop in estimated glomerular filtration rate at Day 90
• on renal replacement therapy (RRT) at day 90 OR on RRT through Day 28

Outcome measures

Measure	Placebo n=319 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3	recAP 1.6 mg/kg n=330 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3
Major Adverse Kidney Events Through Day 90: Combined Population MAKE90A	206 Participants	187 Participants
Major Adverse Kidney Events Through Day 90: Combined Population Death until day 90	111 Participants	112 Participants
Major Adverse Kidney Events Through Day 90: Combined Population Greater than 25% drop in eGFR at Day 90 visit	28 Participants	19 Participants
Major Adverse Kidney Events Through Day 90: Combined Population On RRT at Day 90 visit OR on RRT through day 28	116 Participants	93 Participants
Major Adverse Kidney Events Through Day 90: Combined Population Rehospitalization	30 Participants	28 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Main Trial modified intent-to-treat Population

Days alive and free of organ support through Day 28, ie, days alive with no mechanical ventilation (MV), Renal Replacement Therapy (RRT), vasopressors, or inotropes (with death within 28 days counting as zero days)

Outcome measures

Measure	Placebo n=277 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3	recAP 1.6 mg/kg n=279 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3
Days Alive and Free of Organ Support Through Day 28: Main Trial Population Days alive and free of organ support through to Day 28	13.2 days Standard Deviation 11.33	12.8 days Standard Deviation 11.34
Days Alive and Free of Organ Support Through Day 28: Main Trial Population Number of days free of MV	14.7 days Standard Deviation 11.93	14.3 days Standard Deviation 12.19
Days Alive and Free of Organ Support Through Day 28: Main Trial Population Number of days free of RRT	18.4 days Standard Deviation 12.40	17.9 days Standard Deviation 12.64
Days Alive and Free of Organ Support Through Day 28: Main Trial Population Number of days free of vasopressors and inotropes	16.5 days Standard Deviation 10.85	15.9 days Standard Deviation 11.17

SECONDARY outcome

Timeframe: 28 days

Population: Moderate Chronic Kidney Disease modified intent-to-treat Population

Days alive and free of organ support through Day 28, ie, days alive with no mechanical ventilation (MV), Renal Replacement Therapy (RRT), vasopressors, or inotropes (with death within 28 days counting as zero days)

Outcome measures

Measure	Placebo n=31 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3	recAP 1.6 mg/kg n=30 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3
Days Alive and Free of Organ Support Through Day 28: Moderate Chronic Kidney Disease Population Number of days free of vasopressors and inotropes	14.8 days Standard Deviation 11.15	19.4 days Standard Deviation 10.58
Days Alive and Free of Organ Support Through Day 28: Moderate Chronic Kidney Disease Population Days alive and free of organ support through to Day 28	10.5 days Standard Deviation 10.59	17.2 days Standard Deviation 10.39
Days Alive and Free of Organ Support Through Day 28: Moderate Chronic Kidney Disease Population Number of days free of MV	11.2 days Standard Deviation 11.47	18.1 days Standard Deviation 11.11
Days Alive and Free of Organ Support Through Day 28: Moderate Chronic Kidney Disease Population Number of days free of RRT	17.8 days Standard Deviation 12.81	21.4 days Standard Deviation 11.71

SECONDARY outcome

Timeframe: 28 days

Population: COVID-19 modified intent-to-treat Population

Days alive and free of organ support through Day 28, ie, days alive with no mechanical ventilation (MV), Renal Replacement Therapy (RRT), vasopressors, or inotropes (with death within 28 days counting as zero days)

Outcome measures

Measure	Placebo n=13 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3	recAP 1.6 mg/kg n=20 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3
Days Alive and Free of Organ Support Through Day 28: COVID-19 Population Days alive and free of organ support through to Day 28	1.5 days Standard Deviation 5.27	8.3 days Standard Deviation 10.24
Days Alive and Free of Organ Support Through Day 28: COVID-19 Population Number of days free of MV	3.3 days Standard Deviation 8.14	8.6 days Standard Deviation 10.85
Days Alive and Free of Organ Support Through Day 28: COVID-19 Population Number of days free of RRT	2.3 days Standard Deviation 7.74	19.7 days Standard Deviation 13.09
Days Alive and Free of Organ Support Through Day 28: COVID-19 Population Number of days free of vasopressors and inotropes	3.6 days Standard Deviation 8.83	14.9 days Standard Deviation 11.29

SECONDARY outcome

Timeframe: 28 days

Population: Main Trial modified intent-to-treat Population

Days alive and out of the ICU through Day 28 (with death within 28 days counting as zero days).

Outcome measures

Measure	Placebo n=277 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3	recAP 1.6 mg/kg n=279 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3
Days Alive and Out of the ICU Through Day 28: Main Trial Population	11.4 Days Standard Deviation 10.56	11.4 Days Standard Deviation 10.42

SECONDARY outcome

Timeframe: 28 days

Population: Moderate Chronic Kidney Disease modified intent-to-treat Population

Days alive and out of the ICU through Day 28 (with death within 28 days counting as zero days).

Outcome measures

Measure	Placebo n=31 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3	recAP 1.6 mg/kg n=30 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3
Days Alive and Out of the ICU Through Day 28: Moderate Chronic Kidney Disease Population	8.1 Days Standard Deviation 9.60	14.7 Days Standard Deviation 10.09

SECONDARY outcome

Timeframe: 28 days

Population: COVID-19 modified intent-to-treat Population

Days alive and out of the ICU through Day 28 (with death within 28 days counting as zero days).

Outcome measures

Measure	Placebo n=13 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3	recAP 1.6 mg/kg n=20 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3
Days Alive and Out of the ICU Through Day 28: COVID-19 Population	3.0 Days Standard Deviation 7.39	7.5 Days Standard Deviation 9.60

SECONDARY outcome

Timeframe: 90 days

Population: Main Trial modified intent-to-treat Population

90-Day all-cause mortality

Outcome measures

Measure	Placebo n=277 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3	recAP 1.6 mg/kg n=279 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3
90-day All Cause Mortality: Main Trial Population Participants with event	89 Participants	97 Participants
90-day All Cause Mortality: Main Trial Population Participants censored	188 Participants	182 Participants

SECONDARY outcome

Timeframe: 90 days

Population: Moderate Chronic Kidney Disease modified intent-to-treat Population

90-Day all-cause mortality

Outcome measures

Measure	Placebo n=31 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3	recAP 1.6 mg/kg n=30 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3
90-day All Cause Mortality: Moderate Chronic Kidney Disease Population Participants with event	13 Participants	7 Participants
90-day All Cause Mortality: Moderate Chronic Kidney Disease Population Participants censored	18 Participants	23 Participants

SECONDARY outcome

Timeframe: 90 days

Population: COVID-19 modified intent-to-treat Population

90-Day all-cause mortality

Outcome measures

Measure	Placebo n=13 Participants Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3	recAP 1.6 mg/kg n=20 Participants Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3
90-day All Cause Mortality: COVID-19 Population Participants with event	11 Participants	6 Participants
90-day All Cause Mortality: COVID-19 Population Participants censored	2 Participants	14 Participants

Adverse Events

Placebo (Main Trial Safety Population, n=276)

Serious events: 112 serious events

Other events: 142 other events

Deaths: 92 deaths

recAP 1.6 mg/kg (Main Trial Safety Population, n=280)

Serious events: 125 serious events

Other events: 131 other events

Deaths: 108 deaths

Placebo (Moderate CKD Trial Safety Population, n=31)

Serious events: 18 serious events

Other events: 18 other events

Deaths: 14 deaths

recAP 1.6 mg/kg (Moderate CKD Safety Population, n=30)

Serious events: 11 serious events

Other events: 13 other events

Deaths: 7 deaths

Placebo (Covid-19 Safety Population, n=13)

Serious events: 11 serious events

Other events: 5 other events

Deaths: 11 deaths

recAP 1.6 mg/kg (Covid-19 Safety Population, n=20)

Serious events: 7 serious events

Other events: 12 other events

Deaths: 7 deaths

Serious adverse events

Measure	Placebo (Main Trial Safety Population, n=276) n=276 participants at risk Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 Main Trial Population: Participants with a pre-AKI reference eGFR greater than or equal to 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	recAP 1.6 mg/kg (Main Trial Safety Population, n=280) n=280 participants at risk Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 Main Trial Population: Participants with a pre-AKI reference eGFR greater than or equal to 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	Placebo (Moderate CKD Trial Safety Population, n=31) n=31 participants at risk Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3. Moderate chronic kidney disease (CKD) Population: Participants with a pre-acute kidney injury reference estimated glomerular filtration rate more than or equal to 25 and less than 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	recAP 1.6 mg/kg (Moderate CKD Safety Population, n=30) n=30 participants at risk Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 Moderate chronic kidney disease (CKD) Population: Participants with a pre-acute kidney injury reference estimated glomerular filtration rate more than or equal to 25 and less than 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	Placebo (Covid-19 Safety Population, n=13) n=13 participants at risk Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3. COVID-19 Population: Participants with proven or suspected COVID-19 at time of randomization with or without 'moderate' chronic kidney disease and, for patients in this population, COVID-19 should have been the main cause of sepsis-associated acute kidney injury	recAP 1.6 mg/kg (Covid-19 Safety Population, n=20) n=20 participants at risk Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 COVID-19 Population: Participants with proven or suspected COVID-19 at time of randomization with or without 'moderate' chronic kidney disease and, for patients in this population, COVID-19 should have been the main cause of sepsis-associated acute kidney injury
Nervous system disorders Serotonin syndrome	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Status epilepticus	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Injury, poisoning and procedural complications Drain site complication	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Injury, poisoning and procedural complications Fascial rupture	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Arthritis bacterial	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Septic shock	7.6% 21/276 • Number of events 21 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.7% 16/280 • Number of events 16 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	6.5% 2/31 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Pneumonia	1.8% 5/276 • Number of events 5 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	2.9% 8/280 • Number of events 10 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Sepsis	1.1% 3/276 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.1% 3/280 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Abdominal abscess	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Abdominal infection	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Chest wall abscess	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Endocarditis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Haematoma infection	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Herpes simplex encephalitis	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Infection	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Klebsiella bacteraemia	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Peritonitis	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	6.5% 2/31 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Purulent pericarditis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Cholangitis infective	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Fungaemia	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Herpes simplex pneumonia	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Pneumonia bacterial	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Respiratory failure	5.4% 15/276 • Number of events 15 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.4% 15/280 • Number of events 15 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	38.5% 5/13 • Number of events 5 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	10.0% 2/20 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.4% 4/280 • Number of events 4 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	15.4% 2/13 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Laryngeal oedema	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.1% 3/276 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Cardiac arrest	2.5% 7/276 • Number of events 8 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	2.1% 6/280 • Number of events 6 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Cardiac failure	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Right ventricular failure	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Acute myocardial infarction	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Atrioventricular block complete	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Bradycardia	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Cardiac failure acute	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Cardio-respiratory arrest	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Myocarditis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Pulseless electrical activity	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Tachyarrhythmia	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Torsade de pointes	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Ventricular tachycardia	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Atrial fibrillation	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Atrial flutter	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Atrial thrombosis	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Cardiogenic shock	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Mitral valve incompetence	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Myocardial infarction	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Papillary muscle rupture	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
General disorders Multiple organ dysfunction syndrome	4.3% 12/276 • Number of events 12 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.7% 16/280 • Number of events 16 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	9.7% 3/31 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	10.0% 2/20 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
General disorders Hernia	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Intestinal ischaemia	1.4% 4/276 • Number of events 4 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	2.5% 7/280 • Number of events 7 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Ileus paralytic	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Intestinal perforation	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Large intestine perforation	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Mesenteric venous occlusion	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Abdominal wall haemorrhage	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Duodenal ulcer perforation	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Gastritis haemorrhagic	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Gastrointestinal ischaemia	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Ileus	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Intra-abdominal fluid collection	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Necrotising oesophagitis	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Ischaemic stroke	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Cerebrovascular accident	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Neuropathy peripheral	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Spinal cord compression	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Brain injury	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Cerebellar infarction	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Cerebral haemorrhage	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Cerebral infarction	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Haemorrhage intracranial	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Loss of consciousness	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Neurological decompensation	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Vascular disorders Shock haemorrhagic	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.1% 3/280 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Injury, poisoning and procedural complications Anastomotic leak	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Injury, poisoning and procedural complications Subdural haematoma	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Renal and urinary disorders Acute kidney injury	1.1% 3/276 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.4% 4/280 • Number of events 4 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Vascular disorders Peripheral ischaemia	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Vascular disorders Shock	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Vascular disorders Hypovolaemic shock	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Hepatobiliary disorders Acute hepatic failure	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.1% 3/280 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Hepatobiliary disorders Hepatic failure	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Ear and labyrinth disorders Ear haemorrhage	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Immune system disorders Anaphylactic reaction	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Product Issues Device dislocation	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Psychiatric disorders Schizoaffective disorder	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Blood and lymphatic system disorders Haemolysis	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Musculoskeletal and connective tissue disorders Soft tissue disorder	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Skin and subcutaneous tissue disorders Purpura	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Mesenteric vein thrombosis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Mediastinal abscess	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Cholecystitis infective	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Aspergillus infection	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations COVID-19	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Bacteraemia	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Extradural abscess	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Intervertebral discitis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Cystitis	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Cytomegalovirus enterocolitis	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Escherichia bacteraemia	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Localised infection	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Necrotising soft tissue infection	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Osteomyelitis	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Staphylococcal bacteraemia	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
General disorders Death	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Vascular disorders Circulatory collapse	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Vascular disorders Extremity necrosis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Vascular disorders Deep vein thrombosis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Hepatobiliary disorders Hepatorenal failure	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Hepatobiliary disorders Hepatorenal syndrome	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Hepatobiliary disorders Cholecystitis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasmablastic lymphoma	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Renal and urinary disorders Nephropathy toxic	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Renal and urinary disorders Ureteric obstruction	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Renal and urinary disorders Renal failure	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Injury, poisoning and procedural complications Overdose	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Cerebral ischaemia	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Intensive care unit acquired weakness	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Neuromyopathy	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Bradyarrhythmia	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Pericardial effusion	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Supraventricular tachycardia	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Left ventricular failure	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Gastrointestinal fistula	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Pancreatic mass	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Rectal haemorrhage	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Duodenal perforation	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.

Other adverse events

Measure	Placebo (Main Trial Safety Population, n=276) n=276 participants at risk Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 Main Trial Population: Participants with a pre-AKI reference eGFR greater than or equal to 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	recAP 1.6 mg/kg (Main Trial Safety Population, n=280) n=280 participants at risk Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 Main Trial Population: Participants with a pre-AKI reference eGFR greater than or equal to 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	Placebo (Moderate CKD Trial Safety Population, n=31) n=31 participants at risk Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3. Moderate chronic kidney disease (CKD) Population: Participants with a pre-acute kidney injury reference estimated glomerular filtration rate more than or equal to 25 and less than 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	recAP 1.6 mg/kg (Moderate CKD Safety Population, n=30) n=30 participants at risk Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 Moderate chronic kidney disease (CKD) Population: Participants with a pre-acute kidney injury reference estimated glomerular filtration rate more than or equal to 25 and less than 45 mL/min/1.73 m2 and no proven or suspected COVID-19 at time of randomization	Placebo (Covid-19 Safety Population, n=13) n=13 participants at risk Matching placebo; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3. COVID-19 Population: Participants with proven or suspected COVID-19 at time of randomization with or without 'moderate' chronic kidney disease and, for patients in this population, COVID-19 should have been the main cause of sepsis-associated acute kidney injury	recAP 1.6 mg/kg (Covid-19 Safety Population, n=20) n=20 participants at risk Recombinant human alkaline phosphatase (recAP) 1.6mg/kg; 3 daily 1-hour continuous intravenous infusions on Days 1, 2 and 3 COVID-19 Population: Participants with proven or suspected COVID-19 at time of randomization with or without 'moderate' chronic kidney disease and, for patients in this population, COVID-19 should have been the main cause of sepsis-associated acute kidney injury
Metabolism and nutrition disorders Hypophosphataemia	1.8% 5/276 • Number of events 5 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	2.5% 7/280 • Number of events 7 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Metabolism and nutrition disorders Hypokalaemia	4.3% 12/276 • Number of events 13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.4% 15/280 • Number of events 15 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Metabolism and nutrition disorders Hypernatraemia	3.3% 9/276 • Number of events 9 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.9% 11/280 • Number of events 11 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	10.0% 2/20 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Metabolism and nutrition disorders Hyperkalaemia	1.1% 3/276 • Number of events 4 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	2.9% 8/280 • Number of events 8 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Blood and lymphatic system disorders Anaemia	5.8% 16/276 • Number of events 17 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	9.3% 26/280 • Number of events 26 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	6.5% 2/31 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Blood and lymphatic system disorders Thrombocytopenia	4.7% 13/276 • Number of events 14 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	4.3% 12/280 • Number of events 12 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Atrial fibrillation	8.0% 22/276 • Number of events 23 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	9.3% 26/280 • Number of events 28 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	6.5% 2/31 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	10.0% 3/30 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	15.0% 3/20 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Pneumonia	3.6% 10/276 • Number of events 11 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.4% 4/280 • Number of events 5 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Diarrhoea	3.3% 9/276 • Number of events 9 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.6% 10/280 • Number of events 10 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Psychiatric disorders Confusional state	1.8% 5/276 • Number of events 5 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.6% 10/280 • Number of events 10 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	6.5% 2/31 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Psychiatric disorders Delirium	4.3% 12/276 • Number of events 13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	2.9% 8/280 • Number of events 10 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.9% 8/276 • Number of events 8 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.8% 5/280 • Number of events 5 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	6.5% 2/31 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Vascular disorders Hypertension	2.5% 7/276 • Number of events 7 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	2.1% 6/280 • Number of events 6 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
General disorders Pyrexia	4.0% 11/276 • Number of events 12 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.8% 5/280 • Number of events 6 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Skin and subcutaneous tissue disorders Decubitus ulcer	1.1% 3/276 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	2.9% 8/280 • Number of events 8 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	10.0% 2/20 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Metabolism and nutrition disorders Fluid overload	1.1% 3/276 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.4% 4/280 • Number of events 4 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Metabolism and nutrition disorders Hyperglycaemia	1.1% 3/276 • Number of events 4 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.4% 4/280 • Number of events 4 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Metabolism and nutrition disorders Acidosis	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Blood and lymphatic system disorders Coagulopathy	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.8% 5/280 • Number of events 5 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Blood and lymphatic system disorders Leukocytosis	1.4% 4/276 • Number of events 4 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.1% 3/280 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Blood and lymphatic system disorders Leukopenia	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Atrial flutter	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.8% 5/280 • Number of events 5 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Supraventricular tachycardia	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.1% 3/280 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Bradycardia	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Cardiac ventricular thrombosis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Ventricular tachycardia	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	15.4% 2/13 • Number of events 4 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Aortic valve incompetence	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Cardiac disorders Myocardial ischaemia	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Urinary tract infection	1.1% 3/276 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.1% 3/280 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Abdominal abscess	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Candida infection	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Peritonitis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Escherichia urinary tract infection	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Oral herpes	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Septic shock	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Herpes simplex	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Penile infection	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Abdominal wall infection	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Enterococcal infection	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Endocarditis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Infectious pleural effusion	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Oral candidiasis	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.1% 3/280 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Pneumonia bacterial	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Pneumonia klebsiella	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Infections and infestations Tinea cruris	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Constipation	1.8% 5/276 • Number of events 5 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.1% 3/280 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	10.0% 2/20 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Dysphagia	0.72% 2/276 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.1% 3/280 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Rectal haemorrhage	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Ileus paralytic	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Pancreatic fistula	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Ulcerative gastritis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Gastritis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Psychiatric disorders Anxiety	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.4% 4/280 • Number of events 4 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Psychiatric disorders Agitation	1.1% 3/276 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.1% 3/280 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Psychiatric disorders Insomnia	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Atelectasis	1.1% 3/276 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.1% 3/280 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.1% 3/280 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 4/276 • Number of events 4 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.1% 3/276 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Respiratory, thoracic and mediastinal disorders Pharyngeal swelling	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Vascular disorders Jugular vein thrombosis	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Vascular disorders Haemodynamic instability	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
General disorders Asthenia	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
General disorders Hyperthermia	1.1% 3/276 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
General disorders Oedema peripheral	1.1% 3/276 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	10.0% 2/20 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Psychomotor hyperactivity	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Taste disorder	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Encephalopathy	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Intensive care unit acquired weakness	1.4% 4/276 • Number of events 4 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Ischaemic cerebral infarction	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Ischaemic stroke	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	6.5% 2/31 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Loss of consciousness	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Nervous system disorders Cerebral ischaemia	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Surgical and medical procedures Cholecystectomy	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Surgical and medical procedures Ileostomy	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Surgical and medical procedures Toe amputation	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Endocrine disorders Hypothyroidism	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	1.1% 3/280 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Injury, poisoning and procedural complications Stoma site haemorrhage	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Injury, poisoning and procedural complications Anastomotic leak	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Injury, poisoning and procedural complications Wound dehiscence	1.1% 3/276 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Reproductive system and breast disorders Postmenopausal haemorrhage	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Investigations Lipase increased	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.3% 1/30 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Investigations Blood lactic acid increased	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Investigations Oxygen saturation decreased	0.00% 0/276 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.36% 1/280 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Investigations Transaminases increased	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	3.2% 1/31 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Investigations Gastric residual increased	0.36% 1/276 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Investigations Haemoglobin decreased	1.1% 3/276 • Number of events 3 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.71% 2/280 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/13 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	5.0% 1/20 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.
Investigations Enterococcus test positive	0.72% 2/276 • Number of events 2 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/280 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/31 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/30 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	7.7% 1/13 • Number of events 1 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.	0.00% 0/20 • All AEs were followed to D28, inclusive. Ongoing SAEs on D28 were followed until resolution, deemed to be chronic or not clinically significant, or until the participant was considered stable or was lost to follow-up (up to D180). SAEs starting after D28 were to be reported if at least possibly related to study drug. Patients' mortality status was collected in a separate CRF module up to D180, or date of premature termination. In the safety population participants were analyzed according to treatment received.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee
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