Trial Outcomes & Findings for Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH) (NCT NCT02704403)

NCT ID: NCT02704403

Last Updated: 2022-03-23

Results Overview

To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants with fibrosis by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving NASH resolution without worsening of fibrosis. This outcome measure is for the surrogate endpoint analysis.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 2157 participants
• Primary outcome timeframe: Measurement at 72 weeks
• Results posted on: 2022-03-23

Participant Flow

The version 3 protocol for Brazil is included in the uploaded documents as it was part of the pre-specified plan, but this country was not used as part of the study.

Participant milestones

Measure	120 mg Elafibranor Coated 120mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water	Placebo Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Overall Study STARTED	1437	720
Overall Study Full Intent-to-Treat Population	1437	720
Overall Study Full Safety Population	1433	717
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1437	720

Reasons for withdrawal

Measure	120 mg Elafibranor Coated 120mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water	Placebo Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Overall Study Randomized and not treated (due to non-compliance with protocol)	4	3
Overall Study Administrative reasons by sponsor	1251	616
Overall Study Death	4	3
Overall Study Endpoint event	52	24
Overall Study Lost to Follow-up	22	11
Overall Study Protocol Violation	15	15
Overall Study Adverse Event	2	0
Overall Study Withdrawal by Subject	85	45
Overall Study Investigator decision	1	1
Overall Study Follow-up not possible	1	2

Baseline Characteristics

All participants with data available are presented

Baseline characteristics by cohort

Measure	120 mg Elafibranor n=1437 Participants Coated 120mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water	Placebo n=720 Participants Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water	Total n=2157 Participants Total of all reporting groups
Age, Continuous	54.0 years STANDARD_DEVIATION 11.78 • n=1437 Participants	54.4 years STANDARD_DEVIATION 11.63 • n=720 Participants	54.1 years STANDARD_DEVIATION 11.73 • n=2157 Participants
Sex: Female, Male Female	622 Participants n=1437 Participants	308 Participants n=720 Participants	930 Participants n=2157 Participants
Sex: Female, Male Male	815 Participants n=1437 Participants	412 Participants n=720 Participants	1227 Participants n=2157 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	336 Participants n=1437 Participants	177 Participants n=720 Participants	513 Participants n=2157 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1089 Participants n=1437 Participants	532 Participants n=720 Participants	1621 Participants n=2157 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=1437 Participants	11 Participants n=720 Participants	23 Participants n=2157 Participants
Race (NIH/OMB) American Indian or Alaska Native	8 Participants n=1437 Participants	1 Participants n=720 Participants	9 Participants n=2157 Participants
Race (NIH/OMB) Asian	53 Participants n=1437 Participants	27 Participants n=720 Participants	80 Participants n=2157 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=1437 Participants	3 Participants n=720 Participants	6 Participants n=2157 Participants
Race (NIH/OMB) Black or African American	28 Participants n=1437 Participants	10 Participants n=720 Participants	38 Participants n=2157 Participants
Race (NIH/OMB) White	1234 Participants n=1437 Participants	614 Participants n=720 Participants	1848 Participants n=2157 Participants
Race (NIH/OMB) More than one race	93 Participants n=1437 Participants	49 Participants n=720 Participants	142 Participants n=2157 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=1437 Participants	16 Participants n=720 Participants	34 Participants n=2157 Participants
Weight	98.0 kg STANDARD_DEVIATION 21.90 • n=1437 Participants	96.3 kg STANDARD_DEVIATION 20.84 • n=720 Participants	97.4 kg STANDARD_DEVIATION 21.56 • n=2157 Participants
Height	169.1 cm STANDARD_DEVIATION 10.48 • n=1436 Participants • All participants with data available are presented	168.8 cm STANDARD_DEVIATION 10.23 • n=718 Participants • All participants with data available are presented	169.0 cm STANDARD_DEVIATION 10.39 • n=2154 Participants • All participants with data available are presented
BMI	34.1 kg/m^2 STANDARD_DEVIATION 6.13 • n=1436 Participants • All participants with data available are presented	33.6 kg/m^2 STANDARD_DEVIATION 5.77 • n=718 Participants • All participants with data available are presented	33.9 kg/m^2 STANDARD_DEVIATION 6.01 • n=2154 Participants • All participants with data available are presented
Waist Circumference	111.9 cm STANDARD_DEVIATION 14.19 • n=1431 Participants • All participants with data available are presented	110.4 cm STANDARD_DEVIATION 13.48 • n=719 Participants • All participants with data available are presented	111.4 cm STANDARD_DEVIATION 13.97 • n=2150 Participants • All participants with data available are presented
Child Bearing Potential Yes	105 Participants n=1437 Participants	46 Participants n=720 Participants	151 Participants n=2157 Participants
Child Bearing Potential No	516 Participants n=1437 Participants	262 Participants n=720 Participants	778 Participants n=2157 Participants
Child Bearing Potential Not applicable	815 Participants n=1437 Participants	412 Participants n=720 Participants	1227 Participants n=2157 Participants
Child Bearing Potential Missing	1 Participants n=1437 Participants	0 Participants n=720 Participants	1 Participants n=2157 Participants
Type 2 Diabetes Yes	699 Participants n=1437 Participants	351 Participants n=720 Participants	1050 Participants n=2157 Participants
Type 2 Diabetes No	738 Participants n=1437 Participants	369 Participants n=720 Participants	1107 Participants n=2157 Participants
Fibrosis Stage F1	135 Participants n=1437 Participants	69 Participants n=720 Participants	204 Participants n=2157 Participants
Fibrosis Stage F2	603 Participants n=1437 Participants	302 Participants n=720 Participants	905 Participants n=2157 Participants
Fibrosis Stage F3	699 Participants n=1437 Participants	349 Participants n=720 Participants	1048 Participants n=2157 Participants
Non-alcoholic fatty liver disease Activity Score Grouped Severity Score (categorical) Moderate (4-5)	663 Participants n=1437 Participants	317 Participants n=720 Participants	980 Participants n=2157 Participants
Non-alcoholic fatty liver disease Activity Score Grouped Severity Score (categorical) Severe (greater than or equal to 6)	774 Participants n=1437 Participants	402 Participants n=720 Participants	1176 Participants n=2157 Participants
Non-alcoholic fatty liver disease Activity Score Severity Score (categorical) 4	193 Participants n=1437 Participants	94 Participants n=720 Participants	287 Participants n=2157 Participants
Non-alcoholic fatty liver disease Activity Score Severity Score (categorical) 5	470 Participants n=1437 Participants	223 Participants n=720 Participants	693 Participants n=2157 Participants
Non-alcoholic fatty liver disease Activity Score Severity Score (categorical) 6	453 Participants n=1437 Participants	225 Participants n=720 Participants	678 Participants n=2157 Participants
Non-alcoholic fatty liver disease Activity Score Severity Score (categorical) 7	271 Participants n=1437 Participants	154 Participants n=720 Participants	425 Participants n=2157 Participants
Non-alcoholic fatty liver disease Activity Score Severity Score (categorical) 8	50 Participants n=1437 Participants	23 Participants n=720 Participants	73 Participants n=2157 Participants
Non-alcoholic fatty liver disease Activity Score Severity Score (categorical) Missing	0 Participants n=1437 Participants	1 Participants n=720 Participants	1 Participants n=2157 Participants
Model For End-Stage Liver Disease Score (categorical) Less than 15	1426 Participants n=1437 Participants	715 Participants n=720 Participants	2141 Participants n=2157 Participants
Model For End-Stage Liver Disease Score (categorical) Greater than or equal to 15	11 Participants n=1437 Participants	5 Participants n=720 Participants	16 Participants n=2157 Participants

PRIMARY outcome

Timeframe: Measurement at 72 weeks

Population: Intent-to-treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.

To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants with fibrosis by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving NASH resolution without worsening of fibrosis. This outcome measure is for the surrogate endpoint analysis.

Outcome measures

Measure	120 mg Elafibranor n=717 Participants Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water	Placebo n=353 Participants Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis	138 Participants	52 Participants

PRIMARY outcome

Timeframe: From first randomization up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant)

Population: Full Intent-to-Treat Set: All randomized participants. Participants were analyzed according to their randomized treatment.

Composite long-term outcome measured by the number of participants with the onset of any of the adjudicated events, composed of death due to any cause, histological liver cirrhosis, and the full list of portal hypertension/cirrhosis related events as follows: liver transplantation; model for end stage liver disease (MELD) score greater than or equal to 15 for participants with baseline score less than or equal to 12, and onset of variceal bleeding requiring hospitalization, hepatic encephalopathy with West Haven/Conn score greater than or equal to 2 and requiring hospitalization, spontaneous bacterial peritonitis, and ascites requiring treatment. The MELD scale ranges from 6 to 40, showing how much a participant needs a liver transplant: higher number is more urgent. The West Haven/Conn scale is 5-point (0 to 4) grading severity of hepatic encephalopathy: higher score means worse hepatic encephalopathy. This outcome measure is for the long-term endpoint analysis.

Outcome measures

Measure	120 mg Elafibranor n=1437 Participants Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water	Placebo n=720 Participants Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 12 months · No events or not censored	1277 Participants	637 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 42 months · No events or not censored	83 Participants	36 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 48 months · No events or not censored	2 Participants	1 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 54 months · No events or not censored	0 Participants	0 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes Baseline · Events	0 Participants	0 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes Baseline · Censored	0 Participants	0 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes Baseline · No events or not censored	1437 Participants	720 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 6 months · Events	1 Participants	1 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 6 months · Censored	48 Participants	26 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 6 months · No events or not censored	1388 Participants	693 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 12 months · Events	1 Participants	1 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 12 months · Censored	159 Participants	82 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 18 months · Events	53 Participants	28 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 18 months · Censored	374 Participants	195 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 18 months · No events or not censored	1010 Participants	497 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 24 months · Events	56 Participants	31 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 24 months · Censored	609 Participants	301 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 24 months · No events or not censored	772 Participants	388 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 30 months · Events	57 Participants	31 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 30 months · Censored	778 Participants	393 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 30 months · No events or not censored	602 Participants	296 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 36 months · Events	60 Participants	32 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 36 months · Censored	1049 Participants	531 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 54 months · Events	61 Participants	32 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 36 months · No events or not censored	328 Participants	157 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 42 months · Events	61 Participants	32 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 42 months · Censored	1293 Participants	652 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 48 months · Events	61 Participants	32 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 48 months · Censored	1374 Participants	687 Participants
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes 54 months · Censored	1376 Participants	688 Participants

SECONDARY outcome

Timeframe: Measurements at 72 weeks

Population: Intent-to-Treat Set: For the purpose of analysis sets aligned with efficacy summaries, a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early were considered.

To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving improvement of liver fibrosis of at least 1 stage according to NASH Clinical Research Network (CRN) Scoring. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Outcome measures

Measure	120 mg Elafibranor n=717 Participants Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water	Placebo n=353 Participants Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage	176 Participants	79 Participants

SECONDARY outcome

Timeframe: Measurements after 72 weeks of treatment and up to study termination

Population: Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early. Number of participants with diabetes who had available data at Week 72 are presented.

Hemoglobin A1c (HbA1c) were tested at Week 72. Changes from baseline in HbA1c at Week 72 were evaluated. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Outcome measures

Measure	120 mg Elafibranor n=318 Participants Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water	Placebo n=150 Participants Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Change From Baseline of Hemoglobin A1c (HbA1c) in Diabetic Participants After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo	0.03 mmol/L Interval -0.19 to 0.25	-0.01 mmol/L Interval -0.24 to 0.23

SECONDARY outcome

Timeframe: Measurements after 72 weeks of treatment and up to study termination

Population: Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.

High-density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Outcome measures

Measure	120 mg Elafibranor n=629 Participants Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water	Placebo n=303 Participants Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Change From Baseline of High-density Lipoprotein (HDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo	-0.036 mmol/L Interval -0.05 to -0.021	-0.052 mmol/L Interval -0.073 to -0.032

SECONDARY outcome

Timeframe: Measurements after 72 weeks of treatment and up to study termination

Population: Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.

Low-density lipoprotein (LDL) cholesterol was tested at Week 72. Changes from baseline in LDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Outcome measures

Measure	120 mg Elafibranor n=600 Participants Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water	Placebo n=283 Participants Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Change From Baseline of Low-density Lipoprotein (LDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo	-0.250 mmol/L Interval -0.295 to -0.204	-0.217 mmol/L Interval -0.282 to -0.151

SECONDARY outcome

Timeframe: Measurements after 72 weeks of treatment and up to study termination

Population: Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.

Homeostatic model assessment-IR (HOMA-IR) was tested at Week 72. Changes from baseline in HOMA-IR were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Outcome measures

Measure	120 mg Elafibranor n=311 Participants Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water	Placebo n=152 Participants Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Change From Baseline of Homeostatic Model Assessment-IR (HOMA-IR) After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo in Non-diabetic Participants	-0.789 index Interval -2.979 to 1.402	-0.930 index Interval -3.347 to 1.486

SECONDARY outcome

Timeframe: Measurements after 72 weeks of treatment and up to study termination

Population: Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.

Non-high density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in non-HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Outcome measures

Measure	120 mg Elafibranor n=609 Participants Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water	Placebo n=302 Participants Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Change From Baseline of Non-high Density Lipoprotein Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo	-0.445 mmol/L Interval -0.499 to -0.392	-0.271 mmol/L Interval -0.348 to -0.195

SECONDARY outcome

Timeframe: Measurements after 72 weeks of treatment and up to study termination

Population: Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early.

Triglycerides was tested at Week 72. Changes from baseline in triglycerides were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Outcome measures

Measure	120 mg Elafibranor n=636 Participants Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water	Placebo n=307 Participants Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Change From Baseline of Triglycerides After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo	-0.466 mmol/L Interval -0.537 to -0.395	-0.148 mmol/L Interval -0.249 to -0.046

Adverse Events

120 mg Elafibranor

Serious events: 190 serious events

Other events: 1227 other events

Deaths: 6 deaths

Placebo

Serious events: 95 serious events

Other events: 601 other events

Deaths: 3 deaths

Serious adverse events

Measure	120 mg Elafibranor n=1433 participants at risk Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water	Placebo n=717 participants at risk Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Blood and lymphatic system disorders Hypochromic anaemia	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Blood and lymphatic system disorders Microcytic anaemia	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Atrial fibrillation	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.70% 5/717 • Number of events 6 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Acute myocardial infarction	0.35% 5/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Cardiac failure	0.14% 2/1433 • Number of events 4 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Acute coronary syndrome	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Angina pectoris	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Angina unstable	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Atrial flutter	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Cardiac asthma	0.07% 1/1433 • Number of events 3 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Cardiac failure congestive	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Number of events 2 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Atrial tachycardia	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Atrioventricular block second degree	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Cardiac arrest	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Cardiac failure acute	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Coronary artery disease	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Coronary artery occlusion	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Coronary artery stenosis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Ischaemic cardiomyopathy	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Myocardial infarction	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Palpitations	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Prinzmetal angina	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Cardiac disorders Ventricular tachycardia	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Congenital, familial and genetic disorders Aplasia	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Ear and labyrinth disorders Vertigo	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Endocrine disorders Goitre	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Endocrine disorders Pituitary-dependent Cushing's syndrome	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Endocrine disorders Primary hypothyroidism	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Eye disorders Cataract	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Eye disorders Diplopia	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Eye disorders Optic ischaemic neuropathy	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Eye disorders Retinal detachment	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Eye disorders Retinal vein occlusion	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Eye disorders Vitreous haemorrhage	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Diarrhoea	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.42% 3/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Small intestinal obstruction	0.28% 4/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Abdominal pain	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.42% 3/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Pancreatitis acute	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.28% 2/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Abdominal pain upper	0.21% 3/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Ileus	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Impaired gastric emptying	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.28% 2/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Inguinal hernia	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.28% 2/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Nausea	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Vomiting	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Intestinal obstruction	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Number of events 2 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Crohn's disease	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Pancreatitis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Abdominal hernia	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Appendiceal mucocoele	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Coeliac artery stenosis	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Enteritis	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Gastritis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Gastrointestinal obstruction	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Haemorrhoids thrombosed	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Intra-abdominal fluid collection	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Intussusception	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Pancreatitis necrotising	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Rectal haemorrhage	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Rectal prolapse	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Subileus	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Umbilical hernia	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
General disorders Non-cardiac chest pain	0.35% 5/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.28% 2/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
General disorders Chest pain	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.28% 2/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
General disorders Pyrexia	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
General disorders Asthenia	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
General disorders Gait disturbance	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
General disorders Generalised oedema	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
General disorders Malaise	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
General disorders Oedema peripheral	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Hepatobiliary disorders Cholecystitis	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Hepatobiliary disorders Cholecystitis acute	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Hepatobiliary disorders Bile duct stone	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Hepatobiliary disorders Biliary colic	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Hepatobiliary disorders Biliary obstruction	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Hepatobiliary disorders Cholelithiasis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Hepatobiliary disorders Gallbladder necrosis	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Hepatobiliary disorders Hepatic haematoma	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Hepatobiliary disorders Liver injury	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Pneumonia	0.42% 6/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.42% 3/717 • Number of events 5 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Diverticulitis	0.35% 5/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.28% 2/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Cellulitis	0.21% 3/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.28% 2/717 • Number of events 3 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Urinary tract infection	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.42% 3/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Appendicitis	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Pyelonephritis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.28% 2/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Sepsis	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations COVID-19 pneumonia	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Gastroenteritis	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Gastroenteritis viral	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Device related infection	0.07% 1/1433 • Number of events 2 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Abscess limb	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Arthritis bacterial	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Bronchitis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations COVID-19	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Cystitis	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Diverticulitis intestinal perforated	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Endometritis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Gastroenteritis shigella	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Herpes ophthalmic	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Infected bite	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Infection	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Lower respiratory tract infection	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Meningitis aseptic	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Pharyngitis streptococcal	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Pneumonia influenzal	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Post procedural cellulitis	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Septic shock	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Shigella sepsis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Streptococcal bacteraemia	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Superinfection bacterial	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Vascular device infection	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Viraemia	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Wound infection staphylococcal	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.28% 2/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Ankle fracture	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Rib fracture	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.28% 2/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Procedural pain	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Tendon rupture	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Wound dehiscence	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Bladder injury	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Chest crushing	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Concussion	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Foot fracture	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Incisional hernia	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Post procedural complication	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Procedural pneumothorax	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Road traffic accident	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Seroma	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Skin laceration	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Injury, poisoning and procedural complications Traumatic fracture	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Investigations Liver function test increased	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.28% 2/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Number of events 2 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Metabolism and nutrition disorders Dehydration	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Metabolism and nutrition disorders Hyperkalaemia	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Metabolism and nutrition disorders Hyponatraemia	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Metabolism and nutrition disorders Obesity	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.28% 2/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Metabolism and nutrition disorders Folate deficiency	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Metabolism and nutrition disorders Hyperglycaemia	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.35% 5/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.28% 2/717 • Number of events 3 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.70% 5/717 • Number of events 6 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.28% 4/1433 • Number of events 5 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Back pain	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Muscular weakness	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Arthritis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Flank pain	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Limb discomfort	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders SLE arthritis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Sacroiliitis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Spinal stenosis	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Vertebral lateral recess stenosis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal proliferative breast lesion	0.21% 3/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia recurrent	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma stage IV	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct adenocarcinoma	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Choroid melanoma	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hodgkin's disease	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal metastasis	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lobular breast carcinoma in situ	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant peritoneal neoplasm	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian endometrioid carcinoma	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary cystadenoma lymphomatosum	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary renal cell carcinoma	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour of ampulla of Vater	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Syncope	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.42% 3/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Transient ischaemic attack	0.28% 4/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Cerebrovascular accident	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Lumbar radiculopathy	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Seizure	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Meningocele acquired	0.07% 1/1433 • Number of events 2 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Carotid artery stenosis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Cerebral infarction	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Cervical radiculopathy	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Dementia Alzheimer's type	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Diabetic neuropathy	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Dizziness	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Encephalopathy	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Facial paralysis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Guillain-Barre syndrome	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Haemorrhagic transformation stroke	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Headache	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Ischaemic stroke	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Myasthenia gravis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Parkinson's disease	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Presyncope	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Pyramidal tract syndrome	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Radiculopathy	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Sciatica	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Spinal cord compression	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Tremor	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Vertebral artery dissection	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Wernicke-Korsakoff syndrome	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Product Issues Device malfunction	0.07% 1/1433 • Number of events 3 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Product Issues Device loosening	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Psychiatric disorders Suicidal ideation	0.07% 1/1433 • Number of events 2 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Psychiatric disorders Major depression	0.07% 1/1433 • Number of events 2 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Psychiatric disorders Anxiety disorder	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Psychiatric disorders Behaviour disorder	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Psychiatric disorders Delirium	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Psychiatric disorders Depression	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Psychiatric disorders Depression suicidal	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Psychiatric disorders Drug dependence	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Psychiatric disorders Mental status changes	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Psychiatric disorders Psychiatric decompensation	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Renal and urinary disorders Acute kidney injury	0.21% 3/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.28% 2/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Renal and urinary disorders Renal colic	0.21% 3/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Renal and urinary disorders Chronic kidney disease	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Number of events 2 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Renal and urinary disorders Nephrolithiasis	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Renal and urinary disorders Bladder prolapse	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Renal and urinary disorders Haematuria	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Renal and urinary disorders Nephropathy toxic	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Renal and urinary disorders Renal failure	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Renal and urinary disorders Ureterolithiasis	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Renal and urinary disorders Urinary retention	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Renal and urinary disorders Urinary tract obstruction	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Renal and urinary disorders Urogenital fistula	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.21% 3/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Reproductive system and breast disorders Adnexa uteri mass	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Reproductive system and breast disorders Uterine prolapse	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Respiratory, thoracic and mediastinal disorders Asthma	0.14% 2/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.42% 3/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.14% 2/1433 • Number of events 4 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.28% 2/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Number of events 2 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Respiratory, thoracic and mediastinal disorders Oropharyngeal discomfort	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Respiratory, thoracic and mediastinal disorders Pickwickian syndrome	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Vascular disorders Deep vein thrombosis	0.14% 2/1433 • Number of events 4 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Vascular disorders Hypertension	0.07% 1/1433 • Number of events 3 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Vascular disorders Aortic dissection	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Vascular disorders Aortic stenosis	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Vascular disorders Haematoma	0.00% 0/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.14% 1/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Vascular disorders Hypotension	0.07% 1/1433 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	0.00% 0/717 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.

Other adverse events

Measure	120 mg Elafibranor n=1433 participants at risk Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water	Placebo n=717 participants at risk Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Gastrointestinal disorders Diarrhoea	10.3% 148/1433 • Number of events 171 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	9.5% 68/717 • Number of events 82 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Nausea	9.8% 140/1433 • Number of events 158 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	7.0% 50/717 • Number of events 51 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Abdominal pain upper	5.8% 83/1433 • Number of events 105 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	6.6% 47/717 • Number of events 49 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Gastrointestinal disorders Abdominal pain	5.5% 79/1433 • Number of events 94 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	6.8% 49/717 • Number of events 57 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
General disorders Fatigue	7.2% 103/1433 • Number of events 111 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	6.8% 49/717 • Number of events 54 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Urinary tract infection	10.1% 145/1433 • Number of events 236 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	10.7% 77/717 • Number of events 134 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Nasopharyngitis	9.4% 134/1433 • Number of events 186 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	7.3% 52/717 • Number of events 61 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Influenza	8.0% 115/1433 • Number of events 127 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	7.5% 54/717 • Number of events 68 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Upper respiratory tract infection	7.5% 107/1433 • Number of events 132 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	6.4% 46/717 • Number of events 55 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Bronchitis	6.5% 93/1433 • Number of events 111 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	4.6% 33/717 • Number of events 36 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Infections and infestations Sinusitis	5.0% 72/1433 • Number of events 96 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	6.0% 43/717 • Number of events 53 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Metabolism and nutrition disorders Type 2 diabetes mellitus	7.1% 102/1433 • Number of events 109 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	8.1% 58/717 • Number of events 62 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Arthralgia	11.2% 160/1433 • Number of events 202 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	11.3% 81/717 • Number of events 110 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Back pain	8.4% 120/1433 • Number of events 144 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	8.4% 60/717 • Number of events 62 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 71/1433 • Number of events 77 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	3.5% 25/717 • Number of events 27 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Nervous system disorders Headache	6.8% 98/1433 • Number of events 114 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	6.0% 43/717 • Number of events 46 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 85/1433 • Number of events 99 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	5.6% 40/717 • Number of events 47 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.
Vascular disorders Hypertension	6.0% 86/1433 • Number of events 99 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.	5.4% 39/717 • Number of events 42 • Adverse event information was collected at every study visit from screening up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) plus 30 days. The 9 deaths reported in the all cause mortality section correspond to all death events adjudicated throughout the study duration. Among the 9 deaths, 7 deaths (4 in elafibranor arm; 3 in the placebo arm) resulted in early study discontinuation of participants in the Full Safety Population, as reported in the Participant Flow section.

Additional Information

Carol Addy, MD MMSc

GENFIT

Phone: +01 6179536469

Email: clinicaltrial@genfit.com

Results disclosure agreements

• Principal investigator is a sponsor employee All materials, information (oral or written) and unpublished documentation provided to the Investigators (or any company/institution acting on their behalf) are the exclusive property of the Sponsor and may not be given or disclosed, either in part or in whole, by the Investigator or by any person under his/her authority to any third party without the prior express consent of the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER