Trial Outcomes & Findings for Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B (NCT NCT03491553)

NCT ID: NCT03491553

Last Updated: 2021-08-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 48 participants
• Primary outcome timeframe: Week 24
• Results posted on: 2021-08-19

Participant Flow

Participants were enrolled at study sites in New Zealand and the United States. The first participant was screened on 6 April 2018. The last study visit occurred on 10 August 2020.

59 participants were screened.

Participant milestones

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants Participants with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) remained on their current oral antiviral (OAV) and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/early discontinuation (ED). At Week 48, per Principal Investigator's (PI's) discretion, participants could continue in the Treatment Free Follow-Up (TFFU) phase for up to an additional 48 weeks.	Selgantolimod 3 mg: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Placebo: HBeAg-positive CHB Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Placebo: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
Main Study (Up to Week 48) STARTED	9	10	10	10	5	4
Main Study (Up to Week 48) COMPLETED	8	9	10	9	5	4
Main Study (Up to Week 48) NOT COMPLETED	1	1	0	1	0	0
TFFU (Week 49 up to Additional 48 Weeks) STARTED	0	1	0	0	0	0
TFFU (Week 49 up to Additional 48 Weeks) COMPLETED	0	1	0	0	0	0
TFFU (Week 49 up to Additional 48 Weeks) NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants Participants with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) remained on their current oral antiviral (OAV) and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/early discontinuation (ED). At Week 48, per Principal Investigator's (PI's) discretion, participants could continue in the Treatment Free Follow-Up (TFFU) phase for up to an additional 48 weeks.	Selgantolimod 3 mg: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Placebo: HBeAg-positive CHB Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Placebo: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
Main Study (Up to Week 48) Adverse Event	0	0	0	1	0	0
Main Study (Up to Week 48) Withdrew Consent	1	1	0	0	0	0

Baseline Characteristics

Safety, Tolerability and Antiviral Activity of Selgantolimod in Virally-Suppressed Participants With Chronic Hepatitis B

Baseline characteristics by cohort

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=9 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=10 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Placebo: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Placebo: HBeAg-negative CHB Participants n=4 Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Total n=48 Participants Total of all reporting groups
Age, Continuous	43 years STANDARD_DEVIATION 7.8 • n=5 Participants	46 years STANDARD_DEVIATION 10.1 • n=7 Participants	43 years STANDARD_DEVIATION 5.6 • n=5 Participants	53 years STANDARD_DEVIATION 6.8 • n=4 Participants	43 years STANDARD_DEVIATION 7.9 • n=21 Participants	57 years STANDARD_DEVIATION 10.5 • n=10 Participants	47 years STANDARD_DEVIATION 8.9 • n=115 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	12 Participants n=115 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	9 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=10 Participants	36 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	5 Participants n=21 Participants	4 Participants n=10 Participants	48 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=10 Participants	28 Participants n=115 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	5 Participants n=115 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	4 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	12 Participants n=115 Participants
Race/Ethnicity, Customized White	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Region of Enrollment United States	1 Participants n=5 Participants	7 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	17 Participants n=115 Participants
Region of Enrollment New Zealand	8 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	2 Participants n=10 Participants	31 Participants n=115 Participants
Hepatitis B Surface Antigen (HBsAg)	3.4 log10 IU/mL STANDARD_DEVIATION 0.57 • n=5 Participants	2.6 log10 IU/mL STANDARD_DEVIATION 1.58 • n=7 Participants	3.4 log10 IU/mL STANDARD_DEVIATION 0.62 • n=5 Participants	1.7 log10 IU/mL STANDARD_DEVIATION 1.10 • n=4 Participants	3.3 log10 IU/mL STANDARD_DEVIATION 0.46 • n=21 Participants	3.2 log10 IU/mL STANDARD_DEVIATION 0.42 • n=10 Participants	2.9 log10 IU/mL STANDARD_DEVIATION 1.14 • n=115 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The Full Analysis Set included all randomized participants who took at least 1 dose of the study drug.

Outcome measures

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=9 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=10 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-negative CHB Participants n=4 Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum Quantitative Hepatitis B Surface Antigen (qHBsAg) From Baseline at Week 24	0 percentage of participants Interval 0.0 to 33.6	0 percentage of participants Interval 0.0 to 30.8	0 percentage of participants Interval 0.0 to 30.8	10.0 percentage of participants Interval 0.3 to 44.5	0 percentage of participants Interval 0.0 to 52.2	0 percentage of participants Interval 0.0 to 60.2

SECONDARY outcome

Timeframe: Week 4

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=9 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=10 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-negative CHB Participants n=4 Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 4	0 percentage of participants Interval 0.0 to 33.6	0 percentage of participants Interval 0.0 to 30.8	0 percentage of participants Interval 0.0 to 30.8	0 percentage of participants Interval 0.0 to 30.8	0 percentage of participants Interval 0.0 to 52.2	0 percentage of participants Interval 0.0 to 60.2

SECONDARY outcome

Timeframe: Week 8

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=9 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=10 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-negative CHB Participants n=4 Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 8	0 percentage of participants Interval 0.0 to 33.6	0 percentage of participants Interval 0.0 to 30.8	0 percentage of participants Interval 0.0 to 30.8	0 percentage of participants Interval 0.0 to 30.8	0 percentage of participants Interval 0.0 to 52.2	0 percentage of participants Interval 0.0 to 60.2

SECONDARY outcome

Timeframe: Week 12

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=9 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=10 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-negative CHB Participants n=4 Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 12	0 percentage of participants Interval 0.0 to 33.6	0 percentage of participants Interval 0.0 to 30.8	0 percentage of participants Interval 0.0 to 30.8	0 percentage of participants Interval 0.0 to 30.8	0 percentage of participants Interval 0.0 to 52.2	0 percentage of participants Interval 0.0 to 60.2

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=9 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=10 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-negative CHB Participants n=4 Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Percentage of Participants With ≥ 1 log10 IU/mL Decline in Serum qHBsAg From Baseline at Week 48	0 percentage of participants Interval 0.0 to 33.6	0 percentage of participants Interval 0.0 to 30.8	0 percentage of participants Interval 0.0 to 30.8	10.0 percentage of participants Interval 0.3 to 44.5	0 percentage of participants Interval 0.0 to 52.2	0 percentage of participants Interval 0.0 to 60.2

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=7 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=9 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-negative CHB Participants n=4 Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Change From Baseline in Serum qHBsAg at Week 4	0.02 log10 IU/mL Standard Deviation 0.047	-0.07 log10 IU/mL Standard Deviation 0.110	0.00 log10 IU/mL Standard Deviation 0.070	-0.01 log10 IU/mL Standard Deviation 0.127	-0.02 log10 IU/mL Standard Deviation 0.034	-0.03 log10 IU/mL Standard Deviation 0.058

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=8 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=10 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n=9 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-negative CHB Participants n=4 Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 8	0.00 log10 IU/mL Standard Deviation 0.051	-0.05 log10 IU/mL Standard Deviation 0.117	-0.01 log10 IU/mL Standard Deviation 0.041	-0.04 log10 IU/mL Standard Deviation 0.119	0.02 log10 IU/mL Standard Deviation 0.041	-0.03 log10 IU/mL Standard Deviation 0.061

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=8 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=10 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n=9 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-negative CHB Participants n=4 Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 12	-0.01 log10 IU/mL Standard Deviation 0.059	-0.05 log10 IU/mL Standard Deviation 0.117	0.00 log10 IU/mL Standard Deviation 0.050	-0.04 log10 IU/mL Standard Deviation 0.115	0.05 log10 IU/mL Standard Deviation 0.034	0.00 log10 IU/mL Standard Deviation 0.048

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=8 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=7 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=8 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n=9 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-negative CHB Participants n=4 Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 24	0.01 log10 IU/mL Standard Deviation 0.059	-0.05 log10 IU/mL Standard Deviation 0.136	-0.05 log10 IU/mL Standard Deviation 0.059	-0.16 log10 IU/mL Standard Deviation 0.460	-0.02 log10 IU/mL Standard Deviation 0.048	-0.01 log10 IU/mL Standard Deviation 0.066

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Participants in the Full Analysis Set with available data were analyzed.

Outcome measures

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=8 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=9 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=10 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n=9 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-negative CHB Participants n=4 Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Change From Baseline in Serum qHBsAg (log10 IU/mL) at Week 48	-0.01 log10 IU/mL Standard Deviation 0.073	-0.05 log10 IU/mL Standard Deviation 0.145	-0.07 log10 IU/mL Standard Deviation 0.110	-0.17 log10 IU/mL Standard Deviation 0.523	0.00 log10 IU/mL Standard Deviation 0.049	-0.05 log10 IU/mL Standard Deviation 0.050

SECONDARY outcome

Timeframe: Week 12

Population: Participants in the Full Analysis Set were analyzed.

HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.

Outcome measures

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=9 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=10 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-negative CHB Participants n=4 Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 12	0 percentage of participants	10.0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set were analyzed.

HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.

Outcome measures

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=9 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=10 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-negative CHB Participants n=4 Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Percentage of Participants With HBsAg Loss at Week 24	0 percentage of participants	10.0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set were analyzed.

HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a postbaseline visit.

Outcome measures

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=9 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=10 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-negative CHB Participants n=4 Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Percentage of Participants With HBsAg Loss at Week 48	0 percentage of participants	10.0 percentage of participants	0 percentage of participants	10.0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 12

Population: Participants in the Full Analysis Set were analyzed. Analysis was performed only on HBeAg-positive CHB participants.

HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.

Outcome measures

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=9 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-positive CHB Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Percentage of Participants With HBeAg Loss and Seroconversion at Week 12 HBeAg Loss	0 percentage of participants	10.0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants With HBeAg Loss and Seroconversion at Week 12 HBeAg Loss and Seroconversion	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set were analyzed. Analysis was performed only on HBeAg-positive CHB participants.

HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as HBeAb test changing from negative or missing at baseline to positive at a postbaseline visit.

Outcome measures

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=9 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-positive CHB Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24 HBeAg Loss	0 percentage of participants	10.0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants With HBeAg Loss and Seroconversion at Week 24 HBeAg Loss and Seroconversion	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set were analyzed. Analysis was performed only on HBeAg-positive CHB participants.

HBeAg loss was defined as qualitative HBeAg changing from positive at baseline to negative at a postbaseline visit. HBeAg seroconversion was defined as hepatitis B e antibody (HBeAb) test changing from negative or missing at baseline to positive at a postbaseline visit.

Outcome measures

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=9 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=5 Participants Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-positive CHB Participants Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.	Placebo: HBeAg-negative CHB Participants Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED.
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48 HBeAg Loss	22.2 percentage of participants	10.0 percentage of participants	0 percentage of participants	—	—	—
Percentage of Participants With HBeAg Loss and Seroconversion at Week 48 HBeAg Loss and Seroconversion	11.1 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 48

Population: There were no participants analyzed for the outcome measure since none of the participants met the criteria.

Virologic breakthrough was defined as having two consecutive visits of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 69 IU/mL.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline up to Week 48

Population: There were no participants analyzed for the outcome measure since none of the participants met the criteria.

The criteria for a drug resistance mutation was having two consecutive visits of HBV DNA ≥ 69 IU/mL.

Outcome measures

Outcome data not reported

Adverse Events

Selgantolimod 3 mg: HBeAg-positive CHB Participants

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Selgantolimod 3 mg: HBeAg-negative CHB Participants

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Selgantolimod 1.5 mg: HBeAg-positive CHB Participants

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Selgantolimod 1.5 mg: HBeAg-negative CHB Participants

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo: HBeAg-positive CHB Participants

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo: HBeAg-negative CHB Participants

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=9 participants at risk Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 participants at risk Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=10 participants at risk Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n=10 participants at risk Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Placebo: HBeAg-positive CHB Participants n=5 participants at risk Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Placebo: HBeAg-negative CHB Participants n=4 participants at risk Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
Cardiac disorders Atrial fibrillation	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Eye disorders Iridocyclitis	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Infections and infestations Perineal abscess	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.

Other adverse events

Measure	Selgantolimod 3 mg: HBeAg-positive CHB Participants n=9 participants at risk Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 3 mg: HBeAg-negative CHB Participants n=10 participants at risk Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 3 mg (2 x 1.5 mg tablet) orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg: HBeAg-positive CHB Participants n=10 participants at risk Participants with HBeAg-positive CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Selgantolimod 1.5 mg: HBeAg-negative CHB Participants n=10 participants at risk Participants with HBeAg-negative CHB remained on their current OAV and received selgantolimod 1.5 mg (1 x 1.5 mg tablet) plus 1 tablet of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Placebo: HBeAg-positive CHB Participants n=5 participants at risk Participants with HBeAg-positive CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.	Placebo: HBeAg-negative CHB Participants n=4 participants at risk Participants with HBeAg-negative CHB remained on their current OAV and received 2 tablets of placebo orally on the same day once a week (every 7 days) for 24 doses. After the 24th dose, participants continued their current OAV therapy until Week 48/ED. At Week 48, per PI's discretion, participants could continue in the TFFU phase for up to an additional 48 weeks.
Cardiac disorders Palpitations	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Ear and labyrinth disorders Tinnitus	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	25.0% 1/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Eye disorders Borderline glaucoma	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Eye disorders Cataract nuclear	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	25.0% 1/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Eye disorders Conjunctivitis allergic	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Eye disorders Dry eye	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	50.0% 2/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Eye disorders Eyelids pruritus	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Eye disorders Meibomian gland dysfunction	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Eye disorders Optic disc disorder	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Eye disorders Photophobia	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Eye disorders Pinguecula	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Eye disorders Vision blurred	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Eye disorders Vitreous detachment	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	25.0% 1/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Gastrointestinal disorders Abdominal distension	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Gastrointestinal disorders Abdominal pain	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Gastrointestinal disorders Abdominal pain upper	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Gastrointestinal disorders Constipation	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Gastrointestinal disorders Diarrhoea	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	30.0% 3/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 1/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Gastrointestinal disorders Nausea	66.7% 6/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	50.0% 5/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	30.0% 3/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	40.0% 4/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Gastrointestinal disorders Umbilical hernia	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Gastrointestinal disorders Vomiting	22.2% 2/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	30.0% 3/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	30.0% 3/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
General disorders Asthenia	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
General disorders Catheter site bruise	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
General disorders Chest pain	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
General disorders Chills	22.2% 2/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 2/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 1/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
General disorders Exercise tolerance decreased	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
General disorders Fatigue	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	50.0% 5/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 2/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	25.0% 1/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
General disorders Feeling hot	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
General disorders Malaise	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
General disorders Medical device site dermatitis	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
General disorders Peripheral swelling	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
General disorders Thirst	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Infections and infestations Cellulitis	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Infections and infestations Herpes zoster	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 1/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Infections and infestations Laryngitis	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	25.0% 1/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Infections and infestations Lower respiratory tract infection	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Infections and infestations Perineal abscess	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Infections and infestations Sinusitis	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Infections and infestations Upper respiratory tract infection	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	30.0% 3/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	40.0% 4/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	40.0% 2/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	25.0% 1/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Injury, poisoning and procedural complications Citrate toxicity	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Injury, poisoning and procedural complications Contusion	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 2/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 1/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Investigations Urine output increased	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Metabolism and nutrition disorders Gout	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 2/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Musculoskeletal and connective tissue disorders Back pain	22.2% 2/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 2/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 2/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	40.0% 2/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	25.0% 1/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Musculoskeletal and connective tissue disorders Joint stiffness	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	25.0% 1/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Musculoskeletal and connective tissue disorders Muscle fatigue	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	25.0% 1/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 3/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 2/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Nervous system disorders Dizziness	22.2% 2/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 2/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 1/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Nervous system disorders Dizziness postural	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Nervous system disorders Headache	22.2% 2/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 2/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	30.0% 3/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	40.0% 2/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	50.0% 2/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Nervous system disorders Hypoaesthesia	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 1/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Nervous system disorders Lethargy	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Nervous system disorders Neuropathy peripheral	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Nervous system disorders Taste disorder	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Psychiatric disorders Hypomania	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Psychiatric disorders Insomnia	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Psychiatric disorders Irritability	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Psychiatric disorders Libido decreased	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Renal and urinary disorders Nocturia	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Reproductive system and breast disorders Amenorrhoea	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Reproductive system and breast disorders Menorrhagia	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Reproductive system and breast disorders Pelvic pain	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 2/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 2/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 1/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	22.2% 2/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 1/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 2/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	20.0% 1/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Skin and subcutaneous tissue disorders Rash	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Skin and subcutaneous tissue disorders Skin mass	11.1% 1/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.
Vascular disorders Haematoma	0.00% 0/9 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	10.0% 1/10 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/5 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.	0.00% 0/4 • Adverse Events: First dose date up to last dose date (maximum duration: 24 Weeks) plus 30 days; All Cause Mortality: Randomization up to 28 months Adverse Events: The Safety Analysis Set included all randomized participants who took at least 1 dose of the study drug. All Cause Mortality: All Randomized Analysis Set includes all participants who were randomized in the study.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: GileadClinicalTrials@gilead.com

Results disclosure agreements

• Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
• Publication restrictions are in place

Restriction type: OTHER