Trial Outcomes & Findings for Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension (NCT NCT05001945)

NCT ID: NCT05001945

Last Updated: 2024-01-05

Results Overview

The primary outcome was defined as the change in office-measured (mean of last 2 of 5 unattended measurements using an automated oscillometric sphygmomanometer device after approximately 5 minutes of rest in the seated position) SBP from baseline to the end of Study Week 8. The primary efficacy analysis was performed using a mixed model repeated measures (MMRM) approach with defined fixed effects per the statistical analysis plan. A least-square estimate of the mean difference between each dose group and the placebo group is provided for Week 8.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 200 participants
• Primary outcome timeframe: 8 Weeks
• Results posted on: 2024-01-05

Participant Flow

After successful screening, subjects with plasma renin activity (PRA) ≤1ng/mL/h began a single-blind (SB) run-in period of BID oral treatment with placebo (PBO) in Part 1, and subjects with PRA >1ng/mL/h began a SB QD oral treatment with PBO in Part 2, while continuing on stable doses of background AHT medications. Subjects returned 2 weeks later on Day 1, and those who continued to meet eligibility requirements were randomized in 1:1 fashion with PBO (Part 1), or 6:1 fashion with PBO (Part 2).

Participant milestones

Measure	Placebo - Part 1 Participants received matching placebo, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg BID - Part 1 Participants received 12.5 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 25 mg BID - Part 1 Participants received 25 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg QD - Part 1 Participants received 12.5 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 50 mg QD - Part 1 Participants received 50 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 100 mg QD - Part 1 Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Placebo - Part 2 Participants received matching placebo, taken orally, for 8 weeks in Part 2 of the study	Lorundrostat 100 mg QD - Part 2 Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 2 of the study
Overall Study STARTED	30	22	30	23	28	30	6	31
Overall Study COMPLETED	29	18	28	18	26	27	6	30
Overall Study NOT COMPLETED	1	4	2	5	2	3	0	1

Reasons for withdrawal

Measure	Placebo - Part 1 Participants received matching placebo, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg BID - Part 1 Participants received 12.5 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 25 mg BID - Part 1 Participants received 25 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg QD - Part 1 Participants received 12.5 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 50 mg QD - Part 1 Participants received 50 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 100 mg QD - Part 1 Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Placebo - Part 2 Participants received matching placebo, taken orally, for 8 weeks in Part 2 of the study	Lorundrostat 100 mg QD - Part 2 Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 2 of the study
Overall Study Adverse Event	0	0	0	1	0	0	0	0
Overall Study Lost to Follow-up	0	1	1	2	0	1	0	0
Overall Study Protocol Violation	1	0	1	1	0	1	0	0
Overall Study Withdrawal by Subject	0	0	0	1	1	1	0	1
Overall Study Not specified by Investigator	0	3	0	0	1	0	0	0

Baseline Characteristics

Trial on the Safety and Efficacy of MLS-101 in Patients With Uncontrolled Hypertension

Baseline characteristics by cohort

Measure	Placebo - Part 1 n=30 Participants Participants received matching placebo, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg BID - Part 1 n=22 Participants Participants received 12.5 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 25 mg BID - Part 1 n=30 Participants Participants received 25 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg QD - Part 1 n=23 Participants Participants received 12.5 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 50 mg QD - Part 1 n=28 Participants Participants received 50 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 100 mg QD - Part 1 n=30 Participants Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Placebo - Part 2 n=6 Participants Participants received matching placebo, taken orally, for 8 weeks in Part 2 of the study	Lorundrostat 100 mg QD - Part 2 n=31 Participants Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 2 of the study	Total n=200 Participants Total of all reporting groups
Age, Continuous	62.6 years STANDARD_DEVIATION 10.7 • n=5 Participants	68.1 years STANDARD_DEVIATION 10.1 • n=7 Participants	64.8 years STANDARD_DEVIATION 9.7 • n=5 Participants	65.2 years STANDARD_DEVIATION 11.3 • n=4 Participants	64.7 years STANDARD_DEVIATION 9.5 • n=21 Participants	68.7 years STANDARD_DEVIATION 8.9 • n=8 Participants	62.7 years STANDARD_DEVIATION 12.3 • n=8 Participants	66.6 years STANDARD_DEVIATION 10.6 • n=24 Participants	65.7 years STANDARD_DEVIATION 10.2 • n=42 Participants
Age, Customized <65	17 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants	10 Participants n=4 Participants	15 Participants n=21 Participants	9 Participants n=8 Participants	4 Participants n=8 Participants	8 Participants n=24 Participants	83 Participants n=42 Participants
Age, Customized 65-79	12 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants	10 Participants n=4 Participants	13 Participants n=21 Participants	17 Participants n=8 Participants	2 Participants n=8 Participants	22 Participants n=24 Participants	104 Participants n=42 Participants
Age, Customized >=80	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	13 Participants n=42 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	14 Participants n=7 Participants	19 Participants n=5 Participants	12 Participants n=4 Participants	15 Participants n=21 Participants	18 Participants n=8 Participants	4 Participants n=8 Participants	21 Participants n=24 Participants	120 Participants n=42 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants	13 Participants n=21 Participants	12 Participants n=8 Participants	2 Participants n=8 Participants	10 Participants n=24 Participants	80 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants	10 Participants n=4 Participants	14 Participants n=21 Participants	16 Participants n=8 Participants	2 Participants n=8 Participants	17 Participants n=24 Participants	95 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	12 Participants n=4 Participants	14 Participants n=21 Participants	13 Participants n=8 Participants	4 Participants n=8 Participants	12 Participants n=24 Participants	101 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	2 Participants n=24 Participants	4 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	11 Participants n=4 Participants	8 Participants n=21 Participants	15 Participants n=8 Participants	2 Participants n=8 Participants	6 Participants n=24 Participants	72 Participants n=42 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	15 Participants n=7 Participants	23 Participants n=5 Participants	11 Participants n=4 Participants	19 Participants n=21 Participants	14 Participants n=8 Participants	4 Participants n=8 Participants	25 Participants n=24 Participants	124 Participants n=42 Participants
Race (NIH/OMB) More than one race	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (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	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Region of Enrollment United States	30 participants n=5 Participants	22 participants n=7 Participants	30 participants n=5 Participants	23 participants n=4 Participants	28 participants n=21 Participants	30 participants n=8 Participants	6 participants n=8 Participants	31 participants n=24 Participants	200 participants n=42 Participants
Body Mass Index	31.9 kg/m^2 STANDARD_DEVIATION 4.9 • n=5 Participants	32 kg/m^2 STANDARD_DEVIATION 5.2 • n=7 Participants	30.6 kg/m^2 STANDARD_DEVIATION 5.5 • n=5 Participants	30.6 kg/m^2 STANDARD_DEVIATION 4.9 • n=4 Participants	32.0 kg/m^2 STANDARD_DEVIATION 5.0 • n=21 Participants	30.4 kg/m^2 STANDARD_DEVIATION 5.5 • n=8 Participants	32.0 kg/m^2 STANDARD_DEVIATION 3.9 • n=8 Participants	30.5 kg/m^2 STANDARD_DEVIATION 4.4 • n=24 Participants	31.1 kg/m^2 STANDARD_DEVIATION 5.0 • n=42 Participants
Seated Automated Office-measured Systolic Blood Pressure	142.9 mmHg STANDARD_DEVIATION 10.7 • n=5 Participants	142.6 mmHg STANDARD_DEVIATION 13.3 • n=7 Participants	142.8 mmHg STANDARD_DEVIATION 13.1 • n=5 Participants	142.9 mmHg STANDARD_DEVIATION 13.7 • n=4 Participants	140.0 mmHg STANDARD_DEVIATION 12.1 • n=21 Participants	142.2 mmHg STANDARD_DEVIATION 13.4 • n=8 Participants	135.3 mmHg STANDARD_DEVIATION 5.5 • n=8 Participants	139.8 mmHg STANDARD_DEVIATION 9.1 • n=24 Participants	141.6 mmHg STANDARD_DEVIATION 12.0 • n=42 Participants
Seated Automated Office-measured Diastolic Blood Pressure	83.8 mmHg STANDARD_DEVIATION 9.5 • n=5 Participants	81.6 mmHg STANDARD_DEVIATION 9.4 • n=7 Participants	80.1 mmHg STANDARD_DEVIATION 9.3 • n=5 Participants	80.3 mmHg STANDARD_DEVIATION 12.0 • n=4 Participants	84.7 mmHg STANDARD_DEVIATION 7.0 • n=21 Participants	78.5 mmHg STANDARD_DEVIATION 10.0 • n=8 Participants	81.5 mmHg STANDARD_DEVIATION 7.9 • n=8 Participants	78.6 mmHg STANDARD_DEVIATION 10.0 • n=24 Participants	81.1 mmHg STANDARD_DEVIATION 9.7 • n=42 Participants

PRIMARY outcome

Timeframe: 8 Weeks

Population: The full analysis set included all randomized subjects who received at least 1 dose of randomized study treatment (lorundrostat or placebo). Subjects were analyzed according to the randomized study treatment group. Per the study SAP, modelled analysis comparisons for Part 2 were performed for 100 mg QD Part 2 vs 100mg QD Part 1, and not to Placebo - Part 2. Accordingly, while subjects were analyzed, modelled LSmeans for Placebo - Part 2 were not reported.

The primary outcome was defined as the change in office-measured (mean of last 2 of 5 unattended measurements using an automated oscillometric sphygmomanometer device after approximately 5 minutes of rest in the seated position) SBP from baseline to the end of Study Week 8. The primary efficacy analysis was performed using a mixed model repeated measures (MMRM) approach with defined fixed effects per the statistical analysis plan. A least-square estimate of the mean difference between each dose group and the placebo group is provided for Week 8.

Outcome measures

Measure	Placebo - Part 1 n=29 Participants Participants received matching placebo, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg BID - Part 1 n=19 Participants Participants received 12.5 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 25 mg BID - Part 1 n=28 Participants Participants received 25 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg QD - Part 1 n=19 Participants Participants received 12.5 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 50 mg QD - Part 1 n=28 Participants Participants received 50 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 100 mg QD - Part 1 n=25 Participants Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Placebo - Part 2 Participants received matching placebo, taken orally, for 8 weeks in Part 2 of the study	Lorundrostat 100 mg QD - Part 2 n=31 Participants Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 2 of the study
Change From Baseline in Office-measured Systolic Blood Pressure (SBP) at Study Week 8 Compared to Placebo	-4.10 mmHg Standard Error 2.62	-11.3 mmHg Standard Error 3.15	-11.07 mmHg Standard Error 2.65	-5.63 mmHg Standard Error 3.16	-13.69 mmHg Standard Error 2.67	-11.92 mmHg Standard Error 2.77	—	-11.43 mmHg Standard Error 2.41

SECONDARY outcome

Timeframe: 8 Weeks

Population: The full analysis set included all randomized subjects who received at least 1 dose of randomized study treatment (lorundrostat or placebo). Subjects were analyzed according to the randomized study treatment group. Per the study SAP, modelled analysis comparisons for Part 2 were performed for 100 mg QD Part 2 vs 100mg QD Part 1, and not to Placebo - Part 2. Accordingly, while subjects were analyzed, modelled LSmeans for Placebo - Part 2 were not reported.

The ABPM SBP was measured at baseline and EoT. Change in ABPM-derived mean SBP and DBP from baseline to EoT was analyzed using an ANCOVA with a term for treatment group and a baseline mean 24-hour value as a covariate.

Outcome measures

Measure	Placebo - Part 1 n=26 Participants Participants received matching placebo, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg BID - Part 1 n=16 Participants Participants received 12.5 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 25 mg BID - Part 1 n=26 Participants Participants received 25 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg QD - Part 1 n=15 Participants Participants received 12.5 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 50 mg QD - Part 1 n=28 Participants Participants received 50 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 100 mg QD - Part 1 n=24 Participants Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Placebo - Part 2 Participants received matching placebo, taken orally, for 8 weeks in Part 2 of the study	Lorundrostat 100 mg QD - Part 2 n=27 Participants Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 2 of the study
Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean Systolic Blood Pressure (SBP) and Mean Diastolic Blood Pressure (DBP) From Baseline to End of Treatment (EoT) Mean SBP	-1.01 mmHg Standard Error 2.38	-5.78 mmHg Standard Error 3.03	-9.05 mmHg Standard Error 2.38	-2.51 mmHg Standard Error 3.15	-4.86 mmHg Standard Error 2.34	-6.34 mmHg Standard Error 2.5	—	-1.02 mmHg Standard Error 2.64
Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Mean Systolic Blood Pressure (SBP) and Mean Diastolic Blood Pressure (DBP) From Baseline to End of Treatment (EoT) Mean DBP	-0.90 mmHg Standard Error 1.46	-5.14 mmHg Standard Error 1.85	-6.03 mmHg Standard Error 1.45	-2.34 mmHg Standard Error 1.91	-3.64 mmHg Standard Error 1.40	-6.14 mmHg Standard Error 1.51	—	-0.07 mmHg Standard Error 1.69

SECONDARY outcome

Timeframe: 8 weeks

Population: The full analysis set included all randomized subjects who received at least 1 dose of randomized study treatment (lorundrostat or placebo). Subjects were analyzed according to the randomized study treatment group. Per the study SAP, modelled analysis comparisons for Part 2 were performed for 100 mg QD Part 2 vs 100mg QD Part 1, and not to Placebo - Part 2. Accordingly, while subjects were analyzed, modelled LSmeans for Placebo - Part 2 were not reported.

Change in office-measured (average of last 2 of 5 unattended measurements using an automated oscillometric sphygmomanometer device after approximately 5 minutes of rest in the seated position) DBP from baseline to the end of study at week 8.

Outcome measures

Measure	Placebo - Part 1 n=29 Participants Participants received matching placebo, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg BID - Part 1 n=19 Participants Participants received 12.5 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 25 mg BID - Part 1 n=28 Participants Participants received 25 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg QD - Part 1 n=19 Participants Participants received 12.5 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 50 mg QD - Part 1 n=28 Participants Participants received 50 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 100 mg QD - Part 1 n=25 Participants Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Placebo - Part 2 Participants received matching placebo, taken orally, for 8 weeks in Part 2 of the study	Lorundrostat 100 mg QD - Part 2 n=30 Participants Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 2 of the study
Week 8 Change From Baseline in Office-measured Diastolic Blood Pressure (DBP)	-1.63 mmHg Standard Error 1.66	-5.47 mmHg Standard Error 2.02	-4.12 mmHg Standard Error 1.68	-3.76 mmHg Standard Error 2.02	-7.09 mmHg Standard Error 1.70	-5.75 mmHg Standard Error 1.77	—	-5.55 mmHg Standard Error 1.42

SECONDARY outcome

Timeframe: 8 Weeks

Population: The full analysis set included all randomized subjects who received at least 1 dose of randomized study treatment (lorundrostat or placebo). Subjects were analyzed according to the randomized study treatment group.

Each participant was assessed as a success if the Week 8 value for SBP was ≤130 mmHg and DBP ≤80 mmHg; subjects not meeting both these thresholds were assessed as a failure. Subjects missing an assessment at Week 8 or who received rescue medications were also considered failures.

Outcome measures

Measure	Placebo - Part 1 n=30 Participants Participants received matching placebo, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg BID - Part 1 n=22 Participants Participants received 12.5 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 25 mg BID - Part 1 n=30 Participants Participants received 25 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg QD - Part 1 n=23 Participants Participants received 12.5 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 50 mg QD - Part 1 n=28 Participants Participants received 50 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 100 mg QD - Part 1 n=30 Participants Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Placebo - Part 2 n=6 Participants Participants received matching placebo, taken orally, for 8 weeks in Part 2 of the study	Lorundrostat 100 mg QD - Part 2 n=31 Participants Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 2 of the study
Number of Participants With Blood Pressure ≤ 130/80 mmHg at Week 8	7 Participants	7 Participants	13 Participants	6 Participants	12 Participants	9 Participants	3 Participants	17 Participants

Adverse Events

Placebo - Part 1

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Lorundrostat 12.5 mg BID - Part 1

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Lorundrostat 25 mg BID - Part 1

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Lorundrostat 12.5 mg QD - Part 1

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Lorundrostat 50 mg QD - Part 1

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Lorundrostat 100 mg QD - Part 1

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo - Part 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Lorundrostat 100 mg QD - Part 2

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Run-in

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo - Part 1 n=30 participants at risk Participants received matching placebo, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg BID - Part 1 n=22 participants at risk Participants received 12.5 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 25 mg BID - Part 1 n=30 participants at risk Participants received 25 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg QD - Part 1 n=23 participants at risk Participants received 12.5 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 50 mg QD - Part 1 n=28 participants at risk Participants received 50 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 100 mg QD - Part 1 n=30 participants at risk Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Placebo - Part 2 n=6 participants at risk Participants received matching placebo, taken orally, for 8 weeks in Part 2 of the study	Lorundrostat 100 mg QD - Part 2 n=31 participants at risk Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 2 of the study	Run-in n=305 participants at risk Participants received placebo, taken orally, for up to 2 weeks in the Run-in phase of the study
Cardiac disorders Coronary artery disease	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.3% 1/23 • Number of events 1 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.2% 1/31 • Number of events 1 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.3% 1/23 • Number of events 1 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.

Other adverse events

Measure	Placebo - Part 1 n=30 participants at risk Participants received matching placebo, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg BID - Part 1 n=22 participants at risk Participants received 12.5 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 25 mg BID - Part 1 n=30 participants at risk Participants received 25 mg of lorundrostat twice daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 12.5 mg QD - Part 1 n=23 participants at risk Participants received 12.5 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 50 mg QD - Part 1 n=28 participants at risk Participants received 50 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Lorundrostat 100 mg QD - Part 1 n=30 participants at risk Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 1 of the study	Placebo - Part 2 n=6 participants at risk Participants received matching placebo, taken orally, for 8 weeks in Part 2 of the study	Lorundrostat 100 mg QD - Part 2 n=31 participants at risk Participants received 100 mg of lorundrostat once daily, taken orally, for 8 weeks in Part 2 of the study	Run-in n=305 participants at risk Participants received placebo, taken orally, for up to 2 weeks in the Run-in phase of the study
Gastrointestinal disorders Diarrhoea	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.6% 1/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	6.5% 2/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.66% 2/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Gastrointestinal disorders Nausea	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.3% 1/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	6.5% 2/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.33% 1/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Infections and infestations COVID-19	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.6% 1/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	6.5% 2/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Infections and infestations Urinary Tract Infection	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	10.0% 3/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.3% 1/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	7.1% 2/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	6.5% 2/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Investigations Blood creatinine increased	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	10.0% 3/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.2% 1/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Investigations Blood sodium decreased	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	16.7% 1/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Investigations Cortisol decreased	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	9.1% 2/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Investigations Glomerular filtration rate decreased	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	13.6% 3/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.3% 1/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	16.7% 5/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.2% 1/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	16.7% 1/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Metabolism and nutrition disorders Hyperkalemia	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	22.7% 5/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	30.0% 9/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	26.1% 6/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	10.7% 3/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	26.7% 8/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	25.8% 8/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.98% 3/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	9.7% 3/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Nervous system disorders Dizziness	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.3% 1/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	7.1% 2/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	6.5% 2/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Nervous system disorders Headache	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	6.7% 2/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.6% 1/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Renal and urinary disorders Chronic kidney disease	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	6.5% 2/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Vascular disorders Hypertension	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	8.7% 2/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	7.1% 2/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.33% 1/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Vascular disorders Orthostatic hypotension	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	8.7% 2/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
General disorders Fatigue	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.3% 1/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.2% 1/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
General disorders Peripheral Swelling	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.6% 1/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.33% 1/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Investigations Aspartate aminotransferase increased	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Investigations Haematocrit decreased	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Investigations Haematocrit increased	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Investigations Monocyte count increased	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Investigations Neutrophil count decreased	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Investigations Platelet Count Increased	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Investigations White blood cell count deceased	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Nervous system disorders Neuropathy Peripheral	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Psychiatric disorders Insomnia	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Vascular disorders Hypotension	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.2% 1/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Cardiac disorders Coronary artery disease	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.3% 1/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.6% 1/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
General disorders Swelling	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Investigations Alanine aminotransferase increased	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Investigations Blood corticotrophin decreased	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.3% 1/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Investigations Haemoglobin decreased	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	3.2% 1/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.
Investigations Lymphocyte count increased	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	4.5% 1/22 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/23 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/28 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/30 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/6 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/31 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.	0.00% 0/305 • 12 weeks; two weeks for Run-in Phase treatment-emergent adverse events (TEAEs) reporting and ten weeks for on-treatment (i.e., post-randomization) TEAE reporting. Run-in TEAEs are those that occurred following initiation of study drug dosing in Run-in until initiation of randomized treatment. On-treatment TEAES are those that occurred following randomization (Day 1) until 14 days post last dose of study drug in both Part 1 and Part 2. Subjects with one or more AEs within a level of MedDRA are counted only once in that level.

Additional Information

David Rodman, MD Chief Medical Officer

Mineralys Therapeutics

Phone: 1-888-378-6240

Email: drodman@mineralystx.com

Results disclosure agreements

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

Restriction type: GT60