Trial Outcomes & Findings for Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) (NCT NCT01694849)

NCT ID: NCT01694849

Last Updated: 2022-11-03

Results Overview

Percentage of responders from baseline to Week 52 defined by the disappearance of steatohepatitis (ie, participants no longer meeting the criteria for steatohepatitis) without worsening of fibrosis. Worsening of fibrosis was evaluated using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis staging system and defined as: * Progression to stage 3 or 4 for participants at stage 0, 1 or 2 on diagnostic liver biopsy * Progression to stage 4 for participants at stage 3 on diagnostic liver biopsy

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 275 participants
• Primary outcome timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)
• Results posted on: 2022-11-03

Participant Flow

Recruitment for the GFT505-212-7 study began in September 2012. This was a phase IIb, double-blind, randomized, placebo-controlled study conducted in three parallel groups: placebo, GFT505 80mg and GFT505 120mg (after DSMB review of 6 month safety data of the 80mg dose on at least 50% of participants) once daily for 52 weeks.

Random allocation was done in two phases. In the first study phase, participants were randomly allocated to GFT505 80 mg or placebo (ratio 2:1). In the second study phase (after Data and Safety Monitoring Board review of 6-month safety data of the 80-mg dose on at least 50% of participants), participants were assigned to GFT505 120 mg or placebo (ratio 2:1) in order to balance the 3 treatments in a 1:1:1 ratio basis.

Participant milestones

Measure	GFT505 80mg Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Treatment Period (Visit 2 to Visit 8) STARTED	93	90	92
Treatment Period (Visit 2 to Visit 8) Randomized	93	90	92
Treatment Period (Visit 2 to Visit 8) Randomised and Received Treatment (Full Analysis Set and Safety Set)	93	89	92
Treatment Period (Visit 2 to Visit 8) Efficacy Evaluable Set	82	78	77
Treatment Period (Visit 2 to Visit 8) COMPLETED	84	79	78
Treatment Period (Visit 2 to Visit 8) NOT COMPLETED	9	11	14
Follow-up Period (to Visit 9) STARTED	84	79	78
Follow-up Period (to Visit 9) COMPLETED	83	76	77
Follow-up Period (to Visit 9) NOT COMPLETED	1	3	1

Reasons for withdrawal

Measure	GFT505 80mg Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Treatment Period (Visit 2 to Visit 8) Adverse Event	6	7	4
Treatment Period (Visit 2 to Visit 8) Withdrawal by Subject	1	3	7
Treatment Period (Visit 2 to Visit 8) Lost to Follow-up	0	0	1
Treatment Period (Visit 2 to Visit 8) Protocol Violation	1	0	1
Treatment Period (Visit 2 to Visit 8) Non-compliance	1	0	1
Treatment Period (Visit 2 to Visit 8) Randomized and not treated	0	1	0
Follow-up Period (to Visit 9) Withdrawal by Subject	0	1	0
Follow-up Period (to Visit 9) Lost to Follow-up	1	2	1

Baseline Characteristics

Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)

Baseline characteristics by cohort

Measure	GFT505 80mg n=93 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=89 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=92 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.	Total n=274 Participants Total of all reporting groups
Age, Continuous	53.26 years STANDARD_DEVIATION 11.02 • n=5 Participants	52.88 years STANDARD_DEVIATION 11.63 • n=7 Participants	52.88 years STANDARD_DEVIATION 11.99 • n=5 Participants	53.01 years STANDARD_DEVIATION 11.51 • n=4 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	42 Participants n=7 Participants	37 Participants n=5 Participants	123 Participants n=4 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	47 Participants n=7 Participants	55 Participants n=5 Participants	151 Participants n=4 Participants
Race/Ethnicity, Customized Race · Caucasian	88 Participants n=5 Participants	71 Participants n=7 Participants	85 Participants n=5 Participants	244 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	3 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Body Mass Index (BMI)	31.80 kg/m^2 STANDARD_DEVIATION 5.20 • n=5 Participants	31.04 kg/m^2 STANDARD_DEVIATION 4.39 • n=7 Participants	30.91 kg/m^2 STANDARD_DEVIATION 4.15 • n=5 Participants	31.25 kg/m^2 STANDARD_DEVIATION 4.61 • n=4 Participants
Type 2 diabetes Type 2 diabetes (Yes)	37 participants n=5 Participants	37 participants n=7 Participants	33 participants n=5 Participants	107 participants n=4 Participants
Type 2 diabetes Type 2 diabetes (No)	56 participants n=5 Participants	52 participants n=7 Participants	59 participants n=5 Participants	167 participants n=4 Participants
Height	167.77 cm STANDARD_DEVIATION 9.30 • n=5 Participants	170.21 cm STANDARD_DEVIATION 10.69 • n=7 Participants	169.21 cm STANDARD_DEVIATION 10.23 • n=5 Participants	169.05 cm STANDARD_DEVIATION 10.09 • n=4 Participants
Weight	89.62 kg STANDARD_DEVIATION 17.76 • n=5 Participants	90.15 kg STANDARD_DEVIATION 15.57 • n=7 Participants	88.72 kg STANDARD_DEVIATION 15.79 • n=5 Participants	89.49 kg STANDARD_DEVIATION 16.36 • n=4 Participants
Waist Circumference	106.41 cm STANDARD_DEVIATION 13.09 • n=5 Participants	106.26 cm STANDARD_DEVIATION 10.28 • n=7 Participants	104.68 cm STANDARD_DEVIATION 10.52 • n=5 Participants	105.78 cm STANDARD_DEVIATION 11.37 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Analysis was done of the efficacy evaluable sample, (Efficacy Evaluable Set) formed by participants with liver biopsy available at end-of-treatment and considered as the Intent to Treat population in the protocol. Robustness analysis was also performed in the Full Analysis Set, formed by all randomized participants that received at least one dose of study drug.

Percentage of responders from baseline to Week 52 defined by the disappearance of steatohepatitis (ie, participants no longer meeting the criteria for steatohepatitis) without worsening of fibrosis.

Worsening of fibrosis was evaluated using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis staging system and defined as:

• Progression to stage 3 or 4 for participants at stage 0, 1 or 2 on diagnostic liver biopsy
• Progression to stage 4 for participants at stage 3 on diagnostic liver biopsy

Outcome measures

Measure	GFT505 80mg n=93 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=89 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=92 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) Efficacy evaluable set · Responders	21 Participants	19 Participants	16 Participants
Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) Efficacy evaluable set · Non-responders	61 Participants	59 Participants	61 Participants
Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) Full analysis set · Responders	21 Participants	19 Participants	16 Participants
Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) Full analysis set · Non-responders	72 Participants	70 Participants	76 Participants

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg the change from baseline to Week 52, in Non-alcoholic Fatty Liver Disease Activity Score (NAS score).

NAS score is a composite score equal to the sum of the steatosis grade (0 to 3), lobular inflammation grade (0 to 3) and hepatocellular ballooning grade (0 to 2). The overall scale of the NAS is 0 to 8, with higher scores indicating more severe disease. The outcome measure, change from baseline in NAFLD Activity Score (NAS), has a possible range from -8 to +8, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome.

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score	-0.65 NAS score Standard Deviation 1.33	-0.64 NAS score Standard Deviation 1.68	-0.45 NAS score Standard Deviation 1.34

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate the number of participants with at least a 2 point decrease from baseline in Non-alcoholic Fatty Liver Disease Activity Score (NAS) after 52 weeks of daily administration of GFT505 80mg or 120mg. The NAS refers to the severity of ongoing liver injury as assessed by a liver biopsy and is used to assess the activity of the disease. It is based on the NASH CRN methodology for scoring the severity of steatosis (score of 0 to 3), inflammation (score of 0 to 3), and hepatocellular ballooning (score of 0 to 2), with a maximum score of 8. A total NAS score of five or greater correlates with the diagnosis of steatohepatitis.

In table below for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 2 participants (out of 10 participants analysed with a baseline NAS at 3) had at Least 2 points decrease on their NAS after 52 weeks of daily administration of GFT505 80mg. It corresponds to 20% (2 out of 10).

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Number of Participants With Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score of at Least 2 Points Total	21 Participants	26 Participants	21 Participants
Number of Participants With Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score of at Least 2 Points Mild (Non-alcoholic Fatty Liver Disease Activity Score 3)	2 Participants	2 Participants	5 Participants
Number of Participants With Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score of at Least 2 Points Moderate (Non-alcoholic Fatty Liver Disease Activity Score 4-5)	11 Participants	12 Participants	9 Participants
Number of Participants With Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score of at Least 2 Points Severe (Non-alcoholic Fatty Liver Disease Activity Score 6-8)	8 Participants	12 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in steatosis score of at least 1 point between baseline and Week 52.

Steatosis is assessed by a liver biopsy and evaluated on a scale of 0 to 3 with higher scores indicating more severe steatosis. A score of 0 indicating a lower severity with low parenchymal involvement (<5%), while a score of 3 is indicative of higher involvment/severity (> 66%).

In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease Steatosis Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Number of Participants With Decrease in Steatosis Score of at Least 1 Point Between Baseline and Week 52 Mild (Non-Alcoholic Fatty Liver Disease Activity Score 3)	1 Participants	1 Participants	0 Participants
Number of Participants With Decrease in Steatosis Score of at Least 1 Point Between Baseline and Week 52 Moderate (Non-Alcoholic Fatty Liver Disease Activity Score 4-5)	13 Participants	10 Participants	12 Participants
Number of Participants With Decrease in Steatosis Score of at Least 1 Point Between Baseline and Week 52 Severe (Non-Alcoholic Fatty Liver Disease Activity Score 6-8)	3 Participants	10 Participants	3 Participants
Number of Participants With Decrease in Steatosis Score of at Least 1 Point Between Baseline and Week 52 Total	17 Participants	21 Participants	15 Participants

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in lobular inflammation score of at least 1 point between baseline and Week 52.

Lobular inflammation is assessed by a liver biopsy and evaluated on a scale of 0 to 3. A score of 0 indicating the absence of inflammation loci, while a score of 3 is indicative of a higher degree of inflammation with more than 4 inflammation loci 200 x field.

In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Lobular Inflammation Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Number of Participants With Decrease in Lobular Inflammation Score of at Least 1 Point Between Baseline and Week 52 Mild (Non-Alcoholic Fatty Liver Disease Activity Score 3)	1 Participants	2 Participants	7 Participants
Number of Participants With Decrease in Lobular Inflammation Score of at Least 1 Point Between Baseline and Week 52 Severe (Non-Alcoholic Fatty Liver Disease Activity Score 6-8)	14 Participants	16 Participants	12 Participants
Number of Participants With Decrease in Lobular Inflammation Score of at Least 1 Point Between Baseline and Week 52 Moderate (Non-Alcoholic Fatty Liver Disease Activity Score 4-5)	10 Participants	11 Participants	8 Participants
Number of Participants With Decrease in Lobular Inflammation Score of at Least 1 Point Between Baseline and Week 52 Total	25 Participants	29 Participants	27 Participants

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in ballooning score of at least 1 point between baseline and Week 52.

Ballooning is assessed by a liver biopsy and evaluated on a scale of 0 to 2 with higher scores indicating more severe ballooning (0: No ballooned cells, 1: Few [rare but definite] ballooned hepatocytes; 2: Many ballooned cells/prominent ballooning).

In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 4 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Ballooning Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10).

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Title: Number of Participants With Decrease in Ballooning Score of at Least 1 Point Between Baseline and Week 52 Moderate (Non-Alcoholic Fatty Liver Disease Activity Score 4-5)	17 Participants	15 Participants	13 Participants
Title: Number of Participants With Decrease in Ballooning Score of at Least 1 Point Between Baseline and Week 52 Mild (Non-Alcoholic Fatty Liver Disease Activity Score 3)	4 Participants	3 Participants	6 Participants
Title: Number of Participants With Decrease in Ballooning Score of at Least 1 Point Between Baseline and Week 52 Severe (Non-Alcoholic Fatty Liver Disease Activity Score 6-8)	10 Participants	12 Participants	5 Participants
Title: Number of Participants With Decrease in Ballooning Score of at Least 1 Point Between Baseline and Week 52 Total	31 Participants	30 Participants	24 Participants

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in stages of fibrosis (based on Non-Alcoholic Steatohepatitis Clinical Research Network [NASH CRN] scoring).

Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis.

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in the Stages of Fibrosis	-0.23 Change in fibrosis score Standard Deviation 0.84	-0.06 Change in fibrosis score Standard Deviation 0.96	-0.23 Change in fibrosis score Standard Deviation 0.90

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in liver enzymes.

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Visit 8 (Week 52) in Liver Enzymes Gamma-glutamyl transferase	-24.32 U/L Standard Deviation 36.39	-20.59 U/L Standard Deviation 40.45	6.22 U/L Standard Deviation 50.64
Changes From Baseline to Visit 8 (Week 52) in Liver Enzymes Aspartate transaminase	1.88 U/L Standard Deviation 27.76	-1.37 U/L Standard Deviation 24.74	-1.32 U/L Standard Deviation 16.63
Changes From Baseline to Visit 8 (Week 52) in Liver Enzymes Alanine aminotransferase	-7.02 U/L Standard Deviation 36.21	-12.54 U/L Standard Deviation 44.72	-3.26 U/L Standard Deviation 24.67
Changes From Baseline to Visit 8 (Week 52) in Liver Enzymes Alkaline phosphatases	-18.82 U/L Standard Deviation 13.23	-20.44 U/L Standard Deviation 16.47	3.44 U/L Standard Deviation 13.16

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in aspartate transaminase/alanine aminotransferase ratio

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Visit 8 (Week 52) in Aspartate Transaminase/Alanine Aminotransferase Ratio	0.15 ratio Standard Deviation 0.21	0.20 ratio Standard Deviation 0.25	0.01 ratio Standard Deviation 0.25

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK 18-M65 (non-invasive markers of fibrosis and steatosis).

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK 18-M65	104.4 U/L Standard Deviation 804.96	-185.01 U/L Standard Deviation 658.14	-45.53 U/L Standard Deviation 437.21

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK18 M30 (non-invasive markers of fibrosis and steatosis).

Participants with missing data for CK18 M30 at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=76 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK18 M30	-28.08 pmol/L Standard Deviation 574.50	-66.40 pmol/L Standard Deviation 432.02	-51.39 pmol/L Standard Deviation 349.64

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in adiponectin (non-invasive markers of fibrosis and steatosis).

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Adiponectin	4.98 μg/mL Standard Deviation 20.25	1.90 μg/mL Standard Deviation 8.34	2.54 μg/mL Standard Deviation 9.48

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in ferritin (non-invasive markers of fibrosis and steatosis).

Participants with missing data for Ferritin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.

Outcome measures

Measure	GFT505 80mg n=81 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=77 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=76 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Ferritin	-23.52 μg/L Standard Deviation 145.61	-19.68 μg/L Standard Deviation 81.91	-19.26 μg/L Standard Deviation 122.57

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in FG19 and FG21 (non-invasive markers of fibrosis and steatosis).

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: FG19 and FG21 FG19	-27.25 pg/mL Standard Deviation 94.19	-26.03 pg/mL Standard Deviation 91.59	11.64 pg/mL Standard Deviation 87.10
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: FG19 and FG21 FG21	258.74 pg/mL Standard Deviation 1138.36	319.68 pg/mL Standard Deviation 433.63	73.05 pg/mL Standard Deviation 360.41

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in alpha2 macroglobulin (a non-invasive marker of fibrosis and steatosis).

Participants with missing data for Alpha2 Macroglobulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=77 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=76 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Alpha2 Macroglobulin	-0.14 g/L Standard Deviation 0.29	-0.26 g/L Standard Deviation 0.36	0.01 g/L Standard Deviation 0.28

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in hyaluronic acid, N-terminal pro-peptide of collagen type III (PIIINP), and tissue inhibitor of matrix metalloprotease-1 (TIMP-1) (non-invasive markers of fibrosis and steatosis).

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Hyaluronic Acid, N-terminal Pro-peptide of Collagen Type III (PIIINP), and Tissue Inhibitor of Matrix Metalloprotease-1 (TIMP-1) Hyaluronic acid	26.12 ng/mL Standard Deviation 230.97	12.14 ng/mL Standard Deviation 48.04	12.49 ng/mL Standard Deviation 48.68
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Hyaluronic Acid, N-terminal Pro-peptide of Collagen Type III (PIIINP), and Tissue Inhibitor of Matrix Metalloprotease-1 (TIMP-1) PIIINP	-0.50 ng/mL Standard Deviation 3.43	-0.57 ng/mL Standard Deviation 3.75	0.29 ng/mL Standard Deviation 4.87
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Hyaluronic Acid, N-terminal Pro-peptide of Collagen Type III (PIIINP), and Tissue Inhibitor of Matrix Metalloprotease-1 (TIMP-1) TIMP-1	15.21 ng/mL Standard Deviation 35.38	-6.32 ng/mL Standard Deviation 39.75	9.08 ng/mL Standard Deviation 49.54

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

Fibrotest combines α2-macroglobulin (a2m), apolipoprotein A1 (aA1), total bilirubin (BIL), haptoglobin (h), GGT, and ALT with adjustment for age and gender. Fibrotest is calculated as: z = 4.467 x log(a2m) - 1.357 x log(h) + 1.017 x log(GGT) + 0.0281 x Age + 1.737 x log(BIL) - 1.184 x (aA1) + 0.301 x Gender - 5.54 where Gender = 1 for male and Gender = 0 for female. The score is then: 1/(1+e^-z). Calculated score range from 0 (no fibrosis) to 1 (severe fibrosis or cirrhosis) In below table for "Fibrotest" and for column "GFT505 80mg" the result should be read as: the mean of change from baseline to week 52 of Fibrotest calculated in 81 participants is -0.06 with a standard deviation of 0.08.

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrotest	-0.06 score on a scale Standard Deviation 0.08	-0.07 score on a scale Standard Deviation 0.09	-0.01 score on a scale Standard Deviation 0.10

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

SteatoTest combines α2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT, fasting glucose, triglycerides, cholesterol, and ALT, adjusted for patient's age, sex, weight, and height. Patented formula. Calculated score range from 0 (no steatosis) to 1 (severe steatosis) In below table for "Steatotest" and for column "GFT505 80mg" the result should be read as: the mean of change from baseline to week 52 of Steatotest calculated in 81 participants is -0.09 with a standard deviation of 0.11.

Outcome measures

Measure	GFT505 80mg n=81 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=77 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=74 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Steatotest	-0.09 score on a scale Standard Deviation 0.11	-0.08 score on a scale Standard Deviation 0.15	0.03 score on a scale Standard Deviation 0.11

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score is based on age, hyperglycemia, BMI, platelet count, albumin level, and AST/ALT ratio. Score is calculated using the following formula: -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×10^9/l) - 0.66 × albumin (g/dl). A score of <-1.455 indicates no advanced fibrosis and a score of >0.676 indicates liver fibrosis.

In below table for "Angulo index" and for column "GFT505 80mg" the result should be read as: the mean of change from baseline to week 52 of Angulo index calculated in 82 participants is 0.06 with a standard deviation of 0.53.

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=75 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=76 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score	0.06 score on a scale Standard Deviation 0.53	-0.26 score on a scale Standard Deviation 0.57	-0.01 score on a scale Standard Deviation 0.51

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

Enhanced Liver Fibrosis (ELF) combines measurements of tissue inhibitor of metalloprotein-ases-1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP), and hyaluronic acid (HA) . The ELF score is calculated as : 2.278 + 0.851 ln (HA) + 0.751 ln (PIIINP) + 0.394 ln (TIMP-1). ELF score range from An ELF score of less than 7.7 indicates no fibrosis. An ELF score greater than or equal to 9.8 indicates severe fibrosis. An ELF score of 11.3 or greater indicates cirrhosis. A decrease in ELF score represents a positive outcome In below table for "Enhanced Liver Fibrosis" and for column "GFT505 80mg" the result should be read as : the mean of change from baseline to week 52 of Enhanced Liver Fibrosis calculated in 81 analysed participants is -0.01 with a standard deviation of 0.54.

Outcome measures

Measure	GFT505 80mg n=81 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=76 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Enhanced Liver Fibrosis (ELF)	-0.01 score on a scale Standard Deviation 0.54	-0.01 score on a scale Standard Deviation 0.64	0.08 score on a scale Standard Deviation 0.70

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

The Fatty Liver Index (FLI) combines triglycerides, BMI, GGT and Waist circumference. FLI is calculated as : (e0.953×loge[triglycerides]+0.139× Body Mass Index[BMI]+0.718×loge Gamma- Glutamyl Transferase [GGT]+0.053×waistcircumference-15.745)/ (1 +e0.953×loge[triglycerides]+0.139×BMI+0.718×loge [GGT]+0.053×waistcircumference-15.745) × 100. Calculated index range from 0 to 100. FLI score below 30 indicate absence of Fatty Liver and FLI Score of 60 and above indicates presence of Fatty Liver.

In below table for "Fatty Liver Index" and for column "GFT505 80mg" the result should be read as : the mean of change from baseline to week 52 of Fatty Liver Index calculated in 82 analysed participants is -7.94 with a standard deviation of 11.74.

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=77 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=76 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fatty Liver Index (FLI)	-7.94 score on a scale Standard Deviation 11.74	-7.81 score on a scale Standard Deviation 14.29	1.34 score on a scale Standard Deviation 11.65

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

Fibrometer combines Platelets, AST, ALT, ferritin, glucose (fasting plasma), Weight and gender. Patented formula. Score ranges from 0 (no fibrosis) to 1 (severe fibrosis or cirrhosis) In below table for "Fibrometer" and for column "GFT505 80mg" the result should be read as : the mean of change from baseline to week 52 of Fibrometer calculated in 81 analysed participants is 0.04 with a standard deviation of 0.23.

Outcome measures

Measure	GFT505 80mg n=81 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=74 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=71 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrometer	0.04 score on a scale Standard Deviation 0.23	0 score on a scale Standard Deviation 0.20	0.02 score on a scale Standard Deviation 0.22

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in total bilirubin and conjugated bilirubin (non-invasive markers of fibrosis and steatosis).

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Total Bilirubin and Conjugated Bilirubin Total bilirubin	-1.53 umol/L Standard Deviation 3.66	-1.38 umol/L Standard Deviation 4.85	-1.46 umol/L Standard Deviation 3.77
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Total Bilirubin and Conjugated Bilirubin Conjugated bilirubin	-0.35 umol/L Standard Deviation 1.26	-0.15 umol/L Standard Deviation 1.24	-0.26 umol/L Standard Deviation 1.05

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in prothrombin ratio (non-invasive marker of fibrosis and steatosis).

The Prothrombin ratio is the ratio of a participants measured prothrombin time (in seconds) to the normal laboratory reference prothrombin time.

Participants with missing data for Prothrombin ratio at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=76 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=75 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Prothrombin Ratio	-3.85 ratio Standard Deviation 11.57	1.29 ratio Standard Deviation 10.03	0.51 ratio Standard Deviation 14.28

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in international normalized ratio (INR; non-invasive marker of fibrosis and steatosis).

Participants with missing data for International Normalized Ratio (INR) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=76 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=75 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: International Normalized Ratio (INR)	0.03 ratio Standard Deviation 0.09	-0.01 ratio Standard Deviation 0.08	0.03 ratio Standard Deviation 0.39

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in lipid parameters (used to assess cardiovascular risk)

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Lipid Parameters (Cardiovascular Risk Profile) Very Low Density Lipoproteins Cholesterol	-0.17 mmol/L Standard Deviation 0.28	-0.17 mmol/L Standard Deviation 0.32	0.05 mmol/L Standard Deviation 0.23
Changes From Baseline to Week 52 in Lipid Parameters (Cardiovascular Risk Profile) Low Density Lipoproteins Cholesterol	-0.27 mmol/L Standard Deviation 0.70	-0.25 mmol/L Standard Deviation 0.61	-0.01 mmol/L Standard Deviation 0.51
Changes From Baseline to Week 52 in Lipid Parameters (Cardiovascular Risk Profile) Triglycerides	-0.33 mmol/L Standard Deviation 0.76	-0.48 mmol/L Standard Deviation 0.90	0.16 mmol/L Standard Deviation 1.12
Changes From Baseline to Week 52 in Lipid Parameters (Cardiovascular Risk Profile) Cholesterol	-0.42 mmol/L Standard Deviation 0.78	-0.42 mmol/L Standard Deviation 0.72	0.02 mmol/L Standard Deviation 0.66
Changes From Baseline to Week 52 in Lipid Parameters (Cardiovascular Risk Profile) Non-high Density Lipoproteins Cholesterol	-0.45 mmol/L Standard Deviation 0.79	-0.47 mmol/L Standard Deviation 0.71	0.07 mmol/L Standard Deviation 0.67
Changes From Baseline to Week 52 in Lipid Parameters (Cardiovascular Risk Profile) High Density Lipoproteins Cholesterol	0.02 mmol/L Standard Deviation 0.17	0.06 mmol/L Standard Deviation 0.23	-0.06 mmol/L Standard Deviation 0.21

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in secondary outcomes related to biochemistry

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Outcomes Related to Biochemistry Apo A1	1.63 mg/dL Standard Deviation 15.59	2.85 mg/dL Standard Deviation 20.42	-3.90 mg/dL Standard Deviation 16.53
Changes From Baseline to Week 52 in Outcomes Related to Biochemistry Apo B	-12.80 mg/dL Standard Deviation 20.87	-8.42 mg/dL Standard Deviation 16.03	0.94 mg/dL Standard Deviation 14.29
Changes From Baseline to Week 52 in Outcomes Related to Biochemistry Apo AII	-0.15 mg/dL Standard Deviation 6.63	4.25 mg/dL Standard Deviation 4.36	-3.36 mg/dL Standard Deviation 4.82
Changes From Baseline to Week 52 in Outcomes Related to Biochemistry Lp(a)	-0.57 mg/dL Standard Deviation 12.24	-0.91 mg/dL Standard Deviation 13.75	0.80 mg/dL Standard Deviation 4.46
Changes From Baseline to Week 52 in Outcomes Related to Biochemistry Apo E/B	-1.43 mg/dL Standard Deviation 2.43	-1.48 mg/dL Standard Deviation 2.64	-0.21 mg/dL Standard Deviation 2.59
Changes From Baseline to Week 52 in Outcomes Related to Biochemistry Apo CIII	-1.79 mg/dL Standard Deviation 3.91	-0.69 mg/dL Standard Deviation 3.42	0.77 mg/dL Standard Deviation 4.30
Changes From Baseline to Week 52 in Outcomes Related to Biochemistry Apo CIII/B	-1.44 mg/dL Standard Deviation 2.98	-0.65 mg/dL Standard Deviation 2.98	0.53 mg/dL Standard Deviation 3.05
Changes From Baseline to Week 52 in Outcomes Related to Biochemistry Apo CIII/nonB	-0.35 mg/dL Standard Deviation 1.79	-0.04 mg/dL Standard Deviation 0.76	0.24 mg/dL Standard Deviation 2.53
Changes From Baseline to Week 52 in Outcomes Related to Biochemistry Small dense Low Density Lipoproteins	-2.09 mg/dL Standard Deviation 11.02	-2.62 mg/dL Standard Deviation 6.08	0.60 mg/dL Standard Deviation 7.52
Changes From Baseline to Week 52 in Outcomes Related to Biochemistry Apo E	-1.72 mg/dL Standard Deviation 2.75	-1.38 mg/dL Standard Deviation 2.99	-0.29 mg/dL Standard Deviation 3.67

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in leptin (to assess insulin resistance).

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Insulin Resistance: Leptin	-0.21 ng/mL Standard Deviation 9.55	3.51 ng/mL Standard Deviation 10.67	3.01 ng/mL Standard Deviation 8.08

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in insulin (to assess insulin resistance).

Participants with missing data for Insulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=76 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Insulin Resistance: Insulin	-33.88 pmol/L Standard Deviation 189.64	-26.12 pmol/L Standard Deviation 111.76	8.92 pmol/L Standard Deviation 112.26

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in C peptide (to assess insulin resistance).

Participants with missing data for C Peptide at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.

Outcome measures

Measure	GFT505 80mg n=81 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=77 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=76 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Insulin Resistance: C Peptide	-0.17 nmol/L Standard Deviation 0.55	-0.03 nmol/L Standard Deviation 0.48	0.12 nmol/L Standard Deviation 0.58

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in homeostatic model assessment-insulin resistance (HOMA-IR; to assess insulin resistance).

The HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) x fasting plasma glucose (mmol/l) / 22.5

A decrease in HOMA-IR indicates a positive outcome. HOMA-IR values of greater than 1.9 indicates early insulin resistance and levels above 2.9 indicate significant insulin resistance.

Participants with missing data for HOMA-IR at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.

Outcome measures

Measure	GFT505 80mg n=81 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=76 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Insulin Resistance: Homeostatic Model Assessment-insulin Resistance (HOMA-IR)	-1.10 HOMA-IR score Standard Deviation 10.76	-1 HOMA-IR score Standard Deviation 6.86	1.01 HOMA-IR score Standard Deviation 4.96

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in free fatty acids (FFA; to assess insulin resistance).

Participants with missing data for Free Fatty Acids (FFA) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.

Outcome measures

Measure	GFT505 80mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=76 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Insulin Resistance: Free Fatty Acids (FFA)	-0.04 mmol/L Standard Deviation 0.25	-0.04 mmol/L Standard Deviation 0.24	0.05 mmol/L Standard Deviation 0.26

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in plasma glucose (to assess insulin resistance).

Participants with missing data for Plasma Glucose at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=75 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Insulin Resistance: Plasma Glucose	0.17 mmol/L Standard Deviation 1.23	0.22 mmol/L Standard Deviation 1.70	0.67 mmol/L Standard Deviation 1.95

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in glycosylated haemoglobin A1c (HbA1c; to assess insulin resistance).

Participants with missing data for Haemoglobin A1c (HbA1c) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.

Outcome measures

Measure	GFT505 80mg n=81 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=77 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Insulin Resistance: Glycosylated Haemoglobin A1c (HbA1c)	0.22 percentage of HbA1c Standard Deviation 0.56	0.03 percentage of HbA1c Standard Deviation 0.70	0.25 percentage of HbA1c Standard Deviation 0.69

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in Fructosamine (to assess insulin resistance).

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Insulin Resistance: Fructosamine	16.27 umol/L Standard Deviation 27.53	-8.24 umol/L Standard Deviation 28.21	11.29 umol/L Standard Deviation 28.62

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in fibrinogen and haptoglobin (inflammatory markers).

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Inflammatory Markers: Fibrinogen and Haptoglobin Fibrinogen	-0.37 g/L Standard Deviation 0.70	-0.37 g/L Standard Deviation 0.79	-0.05 g/L Standard Deviation 0.66
Changes From Baseline to Week 52 in Inflammatory Markers: Fibrinogen and Haptoglobin Haptoglobin	-0.19 g/L Standard Deviation 0.32	-0.20 g/L Standard Deviation 0.40	0.09 g/L Standard Deviation 0.35

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in tumour necrosis factor alpha and interleukine 6 (inflammatory markers).

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Inflammatory Markers: Tumour Necrosis Factor Alpha and Interleukine 6 Tumour Necrosis Factor alpha	1.37 pg/mL Standard Deviation 6.14	-2.45 pg/mL Standard Deviation 38.58	0.19 pg/mL Standard Deviation 10.46
Changes From Baseline to Week 52 in Inflammatory Markers: Tumour Necrosis Factor Alpha and Interleukine 6 Interleukine 6	0.37 pg/mL Standard Deviation 4.20	-1.14 pg/mL Standard Deviation 10.33	-0.06 pg/mL Standard Deviation 1.37

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in plasminogen activator inhibitor 1 (PAI-1; inflammatory marker).

Participants with missing data for Plasminogen Activator Inhibitor 1 (PAI-1) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow

Outcome measures

Measure	GFT505 80mg n=68 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=77 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=66 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Inflammatory Markers: Plasminogen Activator Inhibitor 1 (PAI-1)	-0.51 ng/mL Standard Deviation 3.51	0.21 ng/mL Standard Deviation 4.28	-0.14 ng/mL Standard Deviation 4.74

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set

To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in C-Reactive Protein (CRP; inflammatory marker).

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Inflammatory Markers: C-Reactive Protein (CRP)	-0.04 Log (mg/L) Standard Deviation 0.72	-0.05 Log (mg/L) Standard Deviation 0.81	0.20 Log (mg/L) Standard Deviation 0.74

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Safety population

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in creatinine (safety markers; renal function parameter).

Outcome measures

Measure	GFT505 80mg n=93 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=89 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=92 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Safety Markers: Creatinine (Renal Function Parameter)	2.03 μmol/L Standard Deviation 7.89	5.61 μmol/L Standard Deviation 8.18	1.27 μmol/L Standard Deviation 7.85

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Safety population

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in creatinine clearance (safety marker; renal function parameter).

Outcome measures

Measure	GFT505 80mg n=93 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=89 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=92 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Safety Markers: Creatinine Clearance (Renal Function Parameter)	-0.06 mL/min Standard Deviation 0.94	-0.56 mL/min Standard Deviation 2.22	-0.09 mL/min Standard Deviation 0.62

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Safety population

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in uric acid (safety marker; renal function parameter).

Outcome measures

Measure	GFT505 80mg n=93 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=89 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=92 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Safety Markers: Uric Acid (Renal Function Parameter)	0 mmol/L Standard Deviation 0.06	0.01 mmol/L Standard Deviation 0.05	-0.01 mmol/L Standard Deviation 0.06

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Safety population

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in blood urea nitrogen (BUN; safety marker; renal function parameter).

Outcome measures

Measure	GFT505 80mg n=93 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=89 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=92 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Safety Markers: Blood Urea Nitrogen (BUN; Renal Function Parameter)	0.61 mmol urea/L Standard Deviation 1.28	0.67 mmol urea/L Standard Deviation 1.22	-0.17 mmol urea/L Standard Deviation 1.14

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Safety population

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in cystatin C (safety marker; renal function parameter).

Participants with missing data for Cystatin C at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.

Outcome measures

Measure	GFT505 80mg n=93 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=87 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=89 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Safety Markers: Cystatin C (Renal Function Parameter)	0.05 mg/L Standard Deviation 0.10	0.04 mg/L Standard Deviation 0.22	0.04 mg/L Standard Deviation 0.13

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Safety population

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in beta2-microglobulin (safety marker; renal function parameter).

Participants with missing data for Beta2-microglobulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.

Outcome measures

Measure	GFT505 80mg n=93 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=87 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=89 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Safety Markers: Beta2-microglobulin (Renal Function Parameter)	-22.26 μg/L Standard Deviation 326.42	0.11 μg/L Standard Deviation 466.43	-83.48 μg/L Standard Deviation 279.31

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Safety population

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in N-terminal prohormone of brain natriuretic peptide (NT-proBNP; safety marker; cardiac function parameter).

Participants with missing data for NT-proBNP at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.

Outcome measures

Measure	GFT505 80mg n=93 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=87 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=89 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Safety Markers: N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP; Cardiac Function Parameter)	1.54 pmol/L Standard Deviation 4.16	0.38 pmol/L Standard Deviation 4.81	-1.24 pmol/L Standard Deviation 5.35

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Safety population

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in troponin T (safety marker; cardiac function parameter).

Participants with missing data for Troponin T at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow.

Outcome measures

Measure	GFT505 80mg n=92 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=87 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=89 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Safety Markers: Troponin T (Cardiac Function Parameter)	0 μg/L Standard Deviation 0	0 μg/L Standard Deviation 0	0 μg/L Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline (Visit 2; Week 0) to Visit 8 (Week 52)

Population: Efficacy evaluable set (EES)

To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in body weight.

Outcome measures

Measure	GFT505 80mg n=82 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=78 Participants Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=77 Participants Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Changes From Baseline to Week 52 in Body Weight	0.11 kg Standard Deviation 3.61	-0.69 kg Standard Deviation 4.09	-0.04 kg Standard Deviation 3.40

Adverse Events

GFT505 80mg

Serious events: 12 serious events

Other events: 85 other events

Deaths: 0 deaths

GFT505 120mg

Serious events: 14 serious events

Other events: 86 other events

Deaths: 0 deaths

Placebo

Serious events: 9 serious events

Other events: 85 other events

Deaths: 0 deaths

Serious adverse events

Measure	GFT505 80mg n=93 participants at risk Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=89 participants at risk Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=92 participants at risk Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Cardiac disorders Pericarditis	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Ear and labyrinth disorders Vertigo	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Gastrointestinal disorders Abdominal pain	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Gastrointestinal disorders Pancreatitis Acute	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	2.2% 2/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
General disorders Asthenia	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
General disorders Device breakage	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
General disorders Non-cardiac chest pain	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Infections and infestations Clostridium Difficile Infection	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Infections and infestations Device related infection	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Infections and infestations Sepsis	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Injury, poisoning and procedural complications Overdose	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Investigations Blood creatinine increased	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Metabolism and nutrition disorders Diabetes ketoacidosis	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Nervous system disorders Ataxia	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Nervous system disorders Muscle contractions involuntary	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Nervous system disorders Parkinson's disease	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Nervous system disorders Tremor	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Psychiatric disorders Anxiety	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Psychiatric disorders Depression suicidal	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Psychiatric disorders Psychotic disorder	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Renal and urinary disorders Bladder diverticulum	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Renal and urinary disorders Nephrolithiasis	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Reproductive system and breast disorders Benign prostatic hyperplasia	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Surgical and medical procedures Sinus operation	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Surgical and medical procedures Thyroidectomy	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Infections and infestations Gastroenteritis	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Injury, poisoning and procedural complications Hepatic haematoma	1.1% 1/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.

Other adverse events

Measure	GFT505 80mg n=93 participants at risk Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water.	GFT505 120mg n=89 participants at risk Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water.	Placebo n=92 participants at risk Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water.
Gastrointestinal disorders Nausea	19.4% 18/93 • Number of events 23 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	19.1% 17/89 • Number of events 20 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	15.2% 14/92 • Number of events 16 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Gastrointestinal disorders Abdominal pain upper	12.9% 12/93 • Number of events 14 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	10.1% 9/89 • Number of events 11 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	14.1% 13/92 • Number of events 15 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Gastrointestinal disorders Abdominal pain	9.7% 9/93 • Number of events 11 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	12.4% 11/89 • Number of events 12 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	12.0% 11/92 • Number of events 12 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Gastrointestinal disorders Diarrhoea	15.1% 14/93 • Number of events 17 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	10.1% 9/89 • Number of events 9 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	6.5% 6/92 • Number of events 6 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Gastrointestinal disorders Vomiting	7.5% 7/93 • Number of events 8 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	9.0% 8/89 • Number of events 9 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	9.8% 9/92 • Number of events 12 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Gastrointestinal disorders Constipation	7.5% 7/93 • Number of events 8 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	5.6% 5/89 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	5.4% 5/92 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.2% 2/93 • Number of events 3 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	2.2% 2/89 • Number of events 2 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	7.6% 7/92 • Number of events 7 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Gastrointestinal disorders Dyspepsia	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.5% 4/89 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.3% 4/92 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Gastrointestinal disorders Flatulence	2.2% 2/93 • Number of events 2 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/89 • Number of events 1 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.3% 4/92 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
General disorders Fatigue	14.0% 13/93 • Number of events 15 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	13.5% 12/89 • Number of events 14 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	15.2% 14/92 • Number of events 16 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
General disorders Chest pain	4.3% 4/93 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	7.9% 7/89 • Number of events 7 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	3.3% 3/92 • Number of events 3 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
General disorders Asthenia	7.5% 7/93 • Number of events 10 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	5.4% 5/92 • Number of events 6 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
General disorders Influenza like illness	1.1% 1/93 • Number of events 1 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.5% 4/89 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/92 • Number of events 1 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Infections and infestations Bronchitis	10.8% 10/93 • Number of events 11 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	6.7% 6/89 • Number of events 6 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	8.7% 8/92 • Number of events 8 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Infections and infestations Nasopharyngitis	9.7% 9/93 • Number of events 13 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	5.6% 5/89 • Number of events 6 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	5.4% 5/92 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Infections and infestations Influenza	10.8% 10/93 • Number of events 12 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	3.4% 3/89 • Number of events 3 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	5.4% 5/92 • Number of events 6 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Infections and infestations Sinusitis	5.4% 5/93 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	10.1% 9/89 • Number of events 11 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	2.2% 2/92 • Number of events 2 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Infections and infestations Urinary tract infection	6.5% 6/93 • Number of events 10 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	6.7% 6/89 • Number of events 6 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	3.3% 3/92 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Infections and infestations Upper respiratory tract infection	1.1% 1/93 • Number of events 1 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.5% 4/89 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	5.4% 5/92 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Infections and infestations Gastroenteritis	4.3% 4/93 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	2.2% 2/89 • Number of events 3 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Injury, poisoning and procedural complications Procedural pain	6.5% 6/93 • Number of events 6 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	12.4% 11/89 • Number of events 11 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	10.9% 10/92 • Number of events 11 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Investigations Blood creatine phosphokinase increased	4.3% 4/93 • Number of events 6 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	7.9% 7/89 • Number of events 7 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	2.2% 2/92 • Number of events 2 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Investigations Hepatic enzyme increased	4.3% 4/93 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	3.4% 3/89 • Number of events 3 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	3.3% 3/92 • Number of events 3 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Investigations Glycosylated haemoglobin increased	1.1% 1/93 • Number of events 1 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.5% 4/89 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	2.2% 2/92 • Number of events 2 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Investigations Blood creatinine increased	1.1% 1/93 • Number of events 1 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.5% 4/89 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	5.4% 5/93 • Number of events 7 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.5% 4/89 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	5.4% 5/92 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Metabolism and nutrition disorders Hypertriglyceridaemia	5.4% 5/93 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	3.4% 3/89 • Number of events 3 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	3.3% 3/92 • Number of events 3 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Metabolism and nutrition disorders Decreased appetite	4.3% 4/93 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	5.6% 5/89 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/92 • Number of events 1 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Metabolism and nutrition disorders Hyperglycaemia	1.1% 1/93 • Number of events 1 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	2.2% 2/89 • Number of events 2 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.3% 4/92 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/93 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	7.6% 7/92 • Number of events 7 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Musculoskeletal and connective tissue disorders Back pain	7.5% 7/93 • Number of events 9 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	10.1% 9/89 • Number of events 9 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	8.7% 8/92 • Number of events 9 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Musculoskeletal and connective tissue disorders Arthralgia	7.5% 7/93 • Number of events 7 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	10.1% 9/89 • Number of events 10 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	6.5% 6/92 • Number of events 9 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Musculoskeletal and connective tissue disorders Myalgia	9.7% 9/93 • Number of events 9 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	3.4% 3/89 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	3.3% 3/92 • Number of events 3 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Musculoskeletal and connective tissue disorders Muscle spasms	2.2% 2/93 • Number of events 2 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	3.4% 3/89 • Number of events 3 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	6.5% 6/92 • Number of events 7 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	4.3% 4/93 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Nervous system disorders Headache	17.2% 16/93 • Number of events 23 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	13.5% 12/89 • Number of events 14 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	16.3% 15/92 • Number of events 17 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Nervous system disorders Dizziness	10.8% 10/93 • Number of events 12 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	6.7% 6/89 • Number of events 6 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	9.8% 9/92 • Number of events 9 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Psychiatric disorders Anxiety	6.5% 6/93 • Number of events 7 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.5% 4/89 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/92 • Number of events 1 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Psychiatric disorders Insomnia	5.4% 5/93 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	5.6% 5/89 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/92 • Number of events 1 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Psychiatric disorders Sleep disorder	5.4% 5/93 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	2.2% 2/89 • Number of events 2 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.3% 4/92 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Renal and urinary disorders Leukocyturia	10.8% 10/93 • Number of events 12 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	9.0% 8/89 • Number of events 9 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	13.0% 12/92 • Number of events 17 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Renal and urinary disorders Glycosuria	1.1% 1/93 • Number of events 1 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	6.7% 6/89 • Number of events 6 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	3.3% 3/92 • Number of events 3 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Renal and urinary disorders Proteinuria	1.1% 1/93 • Number of events 1 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	2.2% 2/89 • Number of events 2 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	6.5% 6/92 • Number of events 6 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Renal and urinary disorders Renal failure	1.1% 1/93 • Number of events 1 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.5% 4/89 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/92 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Reproductive system and breast disorders Benign prostatic hyperplasia	4.3% 4/93 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	0.00% 0/89 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	1.1% 1/92 • Number of events 1 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Respiratory, thoracic and mediastinal disorders Cough	2.2% 2/93 • Number of events 2 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	6.7% 6/89 • Number of events 6 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	5.4% 5/92 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Skin and subcutaneous tissue disorders Rash	6.5% 6/93 • Number of events 8 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	6.7% 6/89 • Number of events 6 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.3% 4/92 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Skin and subcutaneous tissue disorders Pruritus	3.2% 3/93 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	2.2% 2/89 • Number of events 2 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.3% 4/92 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.2% 3/93 • Number of events 3 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.5% 4/89 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	2.2% 2/92 • Number of events 2 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Skin and subcutaneous tissue disorders Alopecia	1.1% 1/93 • Number of events 1 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	2.2% 2/89 • Number of events 2 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.3% 4/92 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.
Vascular disorders Hypertension	5.4% 5/93 • Number of events 5 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	7.9% 7/89 • Number of events 7 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.	4.3% 4/92 • Number of events 4 • Adverse event information was collected at every study visit from screening up to the termination of the study corresponding to 64 weeks. The investigator established whether or not any adverse event had occurred at each visit (from the date of consent to the last study visit). The participant was questioned in a general manner to determine specific symptoms without offering the patient any suggestion. Serious adverse event reporting began from signature of the participant informed consent form and ended at the last study visit.

Additional Information

Carol Addy, MD MMSc

GENFIT

Phone: +01 6179536469

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