Trial Outcomes & Findings for A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms (NCT NCT03596762)

NCT ID: NCT03596762

Last Updated: 2023-03-10

Results Overview

Participants recorded daily in their electronic diary (eDiary) the frequency and severity of hot flushes during the treatment period. The baseline assessment for hot flushes was calculated using the last 7 days (not necessarily consecutive days) with an available data in the evening and/or the morning of the baseline diary completion period. A diary day was comprised of the evening entry of this day and the morning entry of the following day, in that order. Mean daily frequency = Sum of number of hot flushes filled in the diary during the last 7 diary days (with at least one available data in the evening and/or morning) divided by 7. Moderate: Sensation of heat with sweating, but able to continue activity. Severe: Sensation of heat with sweating, causing cessation (stopping) of activity.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 199 participants
• Primary outcome timeframe: From baseline to Week 4
• Results posted on: 2023-03-10

Participant Flow

The study was conducted between 20 November 2018 (first participant, first visit) and 21 November 2019 (last participant, last visit) at 11 sites in the USA, nine sites in the UK, and five sites in Canada.

A total of 760 participants were screened, of whom 199 completed screening and were randomised. Not meeting the eligibility criteria was the reason provided for all screening failures (561). A total of 47 participants were randomised to placebo and 152 participants to elinzanetant (BAY3427080).

Participant milestones

Measure	Placebo Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) Participants received 4x40 mg elinzanetant capsules.
Overall Study STARTED	47	31	17	52	52
Overall Study COMPLETED	43	30	16	51	45
Overall Study NOT COMPLETED	4	1	1	1	7

Reasons for withdrawal

Measure	Placebo Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) Participants received 4x40 mg elinzanetant capsules.
Overall Study Protocol Violation	0	0	0	0	1
Overall Study Adverse Event	2	0	1	0	5
Overall Study Withdrawal by Subject	2	1	0	1	1

Baseline Characteristics

A Study of BAY3427080 (NT-814) in the Treatment of Moderate to Severe Post-menopausal Vasomotor Symptoms

Baseline characteristics by cohort

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.	Total n=199 Participants Total of all reporting groups
Age, Continuous	55.6 years STANDARD_DEVIATION 4.1 • n=5 Participants	55.4 years STANDARD_DEVIATION 4.0 • n=7 Participants	55.9 years STANDARD_DEVIATION 4.2 • n=5 Participants	54.8 years STANDARD_DEVIATION 4.4 • n=4 Participants	55.0 years STANDARD_DEVIATION 3.8 • n=21 Participants	55.1 years STANDARD_DEVIATION 4.1 • n=8 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	31 Participants n=7 Participants	17 Participants n=5 Participants	52 Participants n=4 Participants	52 Participants n=21 Participants	199 Participants n=8 Participants
Sex: Female, Male Male	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
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants	13 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants	29 Participants n=7 Participants	16 Participants n=5 Participants	50 Participants n=4 Participants	46 Participants n=21 Participants	186 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 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
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=8 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
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants	11 Participants n=21 Participants	38 Participants n=8 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	24 Participants n=7 Participants	13 Participants n=5 Participants	37 Participants n=4 Participants	40 Participants n=21 Participants	152 Participants n=8 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
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants

PRIMARY outcome

Timeframe: From baseline to Week 4

Population: Participants in full analysis set (FAS) with evaluable data.

Participants recorded daily in their electronic diary (eDiary) the frequency and severity of hot flushes during the treatment period. The baseline assessment for hot flushes was calculated using the last 7 days (not necessarily consecutive days) with an available data in the evening and/or the morning of the baseline diary completion period. A diary day was comprised of the evening entry of this day and the morning entry of the following day, in that order. Mean daily frequency = Sum of number of hot flushes filled in the diary during the last 7 diary days (with at least one available data in the evening and/or morning) divided by 7. Moderate: Sensation of heat with sweating, but able to continue activity. Severe: Sensation of heat with sweating, causing cessation (stopping) of activity.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 Baseline	11.82 Hot flushes per day Standard Deviation 4.42	12.13 Hot flushes per day Standard Deviation 8.81	14.55 Hot flushes per day Standard Deviation 5.87	13.54 Hot flushes per day Standard Deviation 7.17	12.92 Hot flushes per day Standard Deviation 6.90
Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 4 Week 4: Change from baseline	-2.45 Hot flushes per day Standard Deviation 3.65	-4.19 Hot flushes per day Standard Deviation 5.78	-4.30 Hot flushes per day Standard Deviation 6.45	-6.76 Hot flushes per day Standard Deviation 5.85	-5.42 Hot flushes per day Standard Deviation 5.36

PRIMARY outcome

Timeframe: From baseline to Week 12

Population: Participants in full analysis set (FAS) with evaluable data.

Participants recorded daily in their electronic diary (eDiary) the frequency and severity of hot flushes during the treatment period. The baseline assessment for hot flushes was calculated using the last 7 days (not necessarily consecutive days) with an available data in the evening and/or the morning of the baseline diary completion period. A diary day was comprised of the evening entry of this day and the morning entry of the following day, in that order. Mean daily frequency = Sum of number of hot flushes filled in the diary during the last 7 diary days (with at least one available data in the evening and/or morning) divided by 7. Moderate: Sensation of heat with sweating, but able to continue activity. Severe: Sensation of heat with sweating, causing cessation (stopping) of activity.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12 Baseline	11.82 Hot flushes per day Standard Deviation 4.42	12.13 Hot flushes per day Standard Deviation 8.81	14.55 Hot flushes per day Standard Deviation 5.87	13.54 Hot flushes per day Standard Deviation 7.17	12.92 Hot flushes per day Standard Deviation 6.90
Mean Change From Baseline in Mean Daily Frequency of Moderate and Severe Hot Flushes From Baseline to Week 12 Week 12: Change from baseline	-4.49 Hot flushes per day Standard Deviation 4.29	-6.48 Hot flushes per day Standard Deviation 7.82	-5.49 Hot flushes per day Standard Deviation 5.31	-7.91 Hot flushes per day Standard Deviation 6.66	-6.57 Hot flushes per day Standard Deviation 5.83

PRIMARY outcome

Timeframe: From baseline to Week 4

Population: Participants in full analysis set (FAS) with evaluable data.

Participants recorded daily in their eDiary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). Severity is graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe).

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4 Baseline	2.54 Hot flushes per day Standard Deviation 0.20	2.51 Hot flushes per day Standard Deviation 0.26	2.63 Hot flushes per day Standard Deviation 0.24	2.54 Hot flushes per day Standard Deviation 0.24	2.54 Hot flushes per day Standard Deviation 0.26
Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 4 Week 4: Change from baseline	-0.31 Hot flushes per day Standard Deviation 0.41	-0.38 Hot flushes per day Standard Deviation 0.54	-0.44 Hot flushes per day Standard Deviation 0.56	-0.51 Hot flushes per day Standard Deviation 0.57	-0.54 Hot flushes per day Standard Deviation 0.67

PRIMARY outcome

Timeframe: From baseline to Week 12

Population: Participants in full analysis set (FAS) with evaluable data.

Participants recorded daily in their eDiary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). Severity was graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe).

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12 Baseline	2.54 Hot flushes per day Standard Deviation 0.20	2.51 Hot flushes per day Standard Deviation 0.26	2.63 Hot flushes per day Standard Deviation 0.24	2.54 Hot flushes per day Standard Deviation 0.24	2.54 Hot flushes per day Standard Deviation 0.26
Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Week 12 Week 12: Change from baseline	-0.41 Hot flushes per day Standard Deviation 0.50	-0.53 Hot flushes per day Standard Deviation 0.64	-0.26 Hot flushes per day Standard Deviation 0.45	-0.56 Hot flushes per day Standard Deviation 0.68	-0.73 Hot flushes per day Standard Deviation 0.78

SECONDARY outcome

Timeframe: From baseline to Weeks 1, 2, 8 and 16

Population: Participants in full analysis set (FAS) with evaluable data.

Participants recorded daily in their electronic diary (eDiary) the frequency and severity of hot flushes during the treatment period. The baseline assessment for hot flushes was calculated using the last 7 days (not necessarily consecutive days) with an available data in the evening and/or the morning of the baseline diary completion period. A diary day was comprised of the evening entry of this day and the morning entry of the following day, in that order. Mean daily frequency = Sum of number of hot flushes filled in the diary during the last 7 diary days (with at least one available data in the evening and/or morning) divided by 7. Moderate: Sensation of heat with sweating, but able to continue activity. Severe: Sensation of heat with sweating, causing cessation (stopping) of activity.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 Baseline	11.82 Hot flushes per day Standard Deviation 4.42	12.13 Hot flushes per day Standard Deviation 8.81	14.55 Hot flushes per day Standard Deviation 5.87	13.54 Hot flushes per day Standard Deviation 7.17	12.92 Hot flushes per day Standard Deviation 6.90
Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 Week 1: Change from baseline	-1.22 Hot flushes per day Standard Deviation 3.07	-1.61 Hot flushes per day Standard Deviation 3.05	-1.63 Hot flushes per day Standard Deviation 3.56	-3.22 Hot flushes per day Standard Deviation 3.43	-3.09 Hot flushes per day Standard Deviation 3.76
Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 Week 2: Change from baseline	-2.19 Hot flushes per day Standard Deviation 4.01	-3.03 Hot flushes per day Standard Deviation 3.95	-3.47 Hot flushes per day Standard Deviation 4.37	-4.58 Hot flushes per day Standard Deviation 4.70	-3.78 Hot flushes per day Standard Deviation 4.48
Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 Week 8: Change from baseline	-4.33 Hot flushes per day Standard Deviation 4.79	-5.72 Hot flushes per day Standard Deviation 6.18	-5.94 Hot flushes per day Standard Deviation 5.26	-7.84 Hot flushes per day Standard Deviation 5.95	-5.58 Hot flushes per day Standard Deviation 6.00
Mean Change From Baseline in Frequency of Mean Daily Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 Week 16: Change from baseline	-3.95 Hot flushes per day Standard Deviation 4.85	-5.74 Hot flushes per day Standard Deviation 9.45	-2.01 Hot flushes per day Standard Deviation 4.99	-5.95 Hot flushes per day Standard Deviation 6.95	-2.78 Hot flushes per day Standard Deviation 6.54

SECONDARY outcome

Timeframe: From baseline to Weeks 1, 2, 8 and 16

Population: Participants in full analysis set (FAS) with evaluable data.

Participants recorded daily in their diary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). Severity is graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe).

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=50 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=50 Participants Participants received 4x40 mg elinzanetant capsules.
Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 Baseline	2.54 Hot flushes per day Standard Deviation 0.20	2.51 Hot flushes per day Standard Deviation 0.26	2.63 Hot flushes per day Standard Deviation 0.24	2.54 Hot flushes per day Standard Deviation 0.24	2.55 Hot flushes per day Standard Deviation 0.26
Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 Week 1: Change from baseline	-0.24 Hot flushes per day Standard Deviation 0.30	-0.21 Hot flushes per day Standard Deviation 0.20	-0.22 Hot flushes per day Standard Deviation 0.21	-0.25 Hot flushes per day Standard Deviation 0.28	-0.26 Hot flushes per day Standard Deviation 0.26
Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 Week 2: Change from baseline	-0.30 Hot flushes per day Standard Deviation 0.39	-0.32 Hot flushes per day Standard Deviation 0.32	-0.42 Hot flushes per day Standard Deviation 0.58	-0.37 Hot flushes per day Standard Deviation 0.46	-0.40 Hot flushes per day Standard Deviation 0.55
Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 Week 8: Change from baseline	-0.45 Hot flushes per day Standard Deviation 0.58	-0.48 Hot flushes per day Standard Deviation 0.54	-0.40 Hot flushes per day Standard Deviation 0.61	-0.51 Hot flushes per day Standard Deviation 0.54	-0.65 Hot flushes per day Standard Deviation 0.73
Mean Change From Baseline in Mean Severity of Moderate and Severe Hot Flushes From Baseline to Weeks 1, 2, 8 and 16 Week 16: Change from baseline	2.15 Hot flushes per day Standard Deviation 0.65	2.03 Hot flushes per day Standard Deviation 0.56	2.50 Hot flushes per day Standard Deviation 0.46	2.13 Hot flushes per day Standard Deviation 0.71	2.08 Hot flushes per day Standard Deviation 0.62

SECONDARY outcome

Timeframe: From baseline to Weeks 1, 2, 4, 8, 12 and 16

Population: Participants in full analysis set (FAS) with evaluable data.

Participants recorded daily in their electronic diary (eDiary) the frequency and severity of hot flushes during the treatment period. The baseline assessment for hot flushes was calculated using the last 7 days (not necessarily consecutive days) with an available data in the evening and/or the morning of the baseline diary completion period. A diary day was comprised of the evening entry of this day and the morning entry of the following day, in that order. Mean daily frequency = Sum of number of hot flushes filled in the diary during the last 7 diary days (with at least one available data in the evening and/or morning) divided by 7. Moderate: Sensation of heat with sweating, but able to continue activity. Severe: Sensation of heat with sweating, causing cessation (stopping) of activity.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 Baseline	14.04 Hot flushes per day Standard Deviation 5.57	14.19 Hot flushes per day Standard Deviation 11.01	16.55 Hot flushes per day Standard Deviation 6.89	15.39 Hot flushes per day Standard Deviation 7.91	15.78 Hot flushes per day Standard Deviation 9.62
Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 Week 1	-1.36 Hot flushes per day Standard Deviation 3.03	-1.72 Hot flushes per day Standard Deviation 3.27	-1.33 Hot flushes per day Standard Deviation 5.68	-3.30 Hot flushes per day Standard Deviation 3.99	-3.69 Hot flushes per day Standard Deviation 4.81
Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 Week 2	-2.35 Hot flushes per day Standard Deviation 4.60	-2.99 Hot flushes per day Standard Deviation 4.90	-2.74 Hot flushes per day Standard Deviation 5.97	-4.57 Hot flushes per day Standard Deviation 5.48	-4.43 Hot flushes per day Standard Deviation 5.68
Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 Week 4	-2.67 Hot flushes per day Standard Deviation 4.09	-4.11 Hot flushes per day Standard Deviation 6.31	-3.45 Hot flushes per day Standard Deviation 8.54	-6.70 Hot flushes per day Standard Deviation 6.16	-5.79 Hot flushes per day Standard Deviation 6.09
Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 Week 8	-4.74 Hot flushes per day Standard Deviation 5.57	-5.65 Hot flushes per day Standard Deviation 6.55	-5.45 Hot flushes per day Standard Deviation 6.56	-7.96 Hot flushes per day Standard Deviation 6.16	-6.03 Hot flushes per day Standard Deviation 6.43
Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 Week 12	-5.07 Hot flushes per day Standard Deviation 5.48	-6.50 Hot flushes per day Standard Deviation 8.67	-5.11 Hot flushes per day Standard Deviation 8.41	-7.94 Hot flushes per day Standard Deviation 6.74	-7.47 Hot flushes per day Standard Deviation 7.13
Mean Change From Baseline in Mean Daily Frequency of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 Week 16	-4.60 Hot flushes per day Standard Deviation 6.17	-5.83 Hot flushes per day Standard Deviation 10.86	-1.76 Hot flushes per day Standard Deviation 7.50	-6.19 Hot flushes per day Standard Deviation 7.68	-3.11 Hot flushes per day Standard Deviation 6.71

SECONDARY outcome

Timeframe: From baseline to Weeks 1, 2, 4, 8, 12 and 16

Population: Participants with available data are reported.

Participants recorded daily in their diary the frequency and severity of hot flushes during the treatment period. Mean weekly severity = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). Severity is graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe).

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 Week 2: Change from baseline	-0.10 Hot flushes per day Standard Deviation 0.32	-0.15 Hot flushes per day Standard Deviation 0.27	-0.25 Hot flushes per day Standard Deviation 0.52	-0.21 Hot flushes per day Standard Deviation 0.46	-0.20 Hot flushes per day Standard Deviation 0.50
Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 Week 4: Change from baseline	-0.11 Hot flushes per day Standard Deviation 0.36	-0.21 Hot flushes per day Standard Deviation 0.47	-0.27 Hot flushes per day Standard Deviation 0.49	-0.35 Hot flushes per day Standard Deviation 0.60	-0.34 Hot flushes per day Standard Deviation 0.63
Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 Week 8: Change from baseline	-0.25 Hot flushes per day Standard Deviation 0.54	-0.31 Hot flushes per day Standard Deviation 0.47	-0.23 Hot flushes per day Standard Deviation 0.52	-0.35 Hot flushes per day Standard Deviation 0.55	-0.44 Hot flushes per day Standard Deviation 0.72
Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 Baseline	2.34 Hot flushes per day Standard Deviation 0.32	2.34 Hot flushes per day Standard Deviation 0.35	2.46 Hot flushes per day Standard Deviation 0.37	2.38 Hot flushes per day Standard Deviation 0.34	2.35 Hot flushes per day Standard Deviation 0.39
Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 Week 1: Change from baseline	-0.04 Hot flushes per day Standard Deviation 0.23	-0.04 Hot flushes per day Standard Deviation 0.18	-0.05 Hot flushes per day Standard Deviation 0.12	-0.09 Hot flushes per day Standard Deviation 0.25	-0.07 Hot flushes per day Standard Deviation 0.18
Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 Week 12: Change from baseline	-0.21 Hot flushes per day Standard Deviation 0.44	-0.35 Hot flushes per day Standard Deviation 0.57	-0.08 Hot flushes per day Standard Deviation 0.41	-0.41 Hot flushes per day Standard Deviation 0.62	-0.52 Hot flushes per day Standard Deviation 0.79
Mean Change From Baseline in Mean Severity of All Hot Flushes From Baseline to Weeks 1, 2, 4, 8, 12 and 16 Week 16: Change from baseline	-0.21 Hot flushes per day Standard Deviation 0.49	-0.30 Hot flushes per day Standard Deviation 0.52	0.05 Hot flushes per day Standard Deviation 0.34	-0.26 Hot flushes per day Standard Deviation 0.56	-0.24 Hot flushes per day Standard Deviation 0.54

SECONDARY outcome

Timeframe: From baseline to Weeks 1, 2, 4, 8, 12 and 16

Population: Participants in full analysis set (FAS) with evaluable data.

Mean daily Hot Flushes score = Sum of (frequency x severity) filled in the diary during the last 7 days (with at least one available data in the evening and/or morning) divided by 7. Severity is graded by the women from 1 to 3 (1 = mild; 2 = moderate; 3 = severe).

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 Baseline	32.35 (units on a scale)*(hot flushes per day) Standard Deviation 12.24	32.84 (units on a scale)*(hot flushes per day) Standard Deviation 24.82	40.76 (units on a scale)*(hot flushes per day) Standard Deviation 17.08	36.59 (units on a scale)*(hot flushes per day) Standard Deviation 19.88	35.73 (units on a scale)*(hot flushes per day) Standard Deviation 19.75
Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 Week 1: Change from baseline	-3.09 (units on a scale)*(hot flushes per day) Standard Deviation 8.16	-4.26 (units on a scale)*(hot flushes per day) Standard Deviation 7.93	-4.18 (units on a scale)*(hot flushes per day) Standard Deviation 11.27	-8.44 (units on a scale)*(hot flushes per day) Standard Deviation 8.98	-8.67 (units on a scale)*(hot flushes per day) Standard Deviation 10.53
Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 Week 2: Change from baseline	-5.62 (units on a scale)*(hot flushes per day) Standard Deviation 11.00	-7.88 (units on a scale)*(hot flushes per day) Standard Deviation 10.77	-9.08 (units on a scale)*(hot flushes per day) Standard Deviation 13.09	-11.98 (units on a scale)*(hot flushes per day) Standard Deviation 12.39	-10.51 (units on a scale)*(hot flushes per day) Standard Deviation 12.47
Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 Week 4: Change from baseline	-6.62 (units on a scale)*(hot flushes per day) Standard Deviation 9.79	-10.68 (units on a scale)*(hot flushes per day) Standard Deviation 15.26	-11.39 (units on a scale)*(hot flushes per day) Standard Deviation 18.82	-17.54 (units on a scale)*(hot flushes per day) Standard Deviation 15.50	-14.20 (units on a scale)*(hot flushes per day) Standard Deviation 14.30
Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 Week 8: Change from baseline	-11.63 (units on a scale)*(hot flushes per day) Standard Deviation 12.51	-14.64 (units on a scale)*(hot flushes per day) Standard Deviation 16.33	-16.17 (units on a scale)*(hot flushes per day) Standard Deviation 15.32	-20.54 (units on a scale)*(hot flushes per day) Standard Deviation 15.80	-14.89 (units on a scale)*(hot flushes per day) Standard Deviation 15.36
Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 Week 12: Change from baseline	-12.33 (units on a scale)*(hot flushes per day) Standard Deviation 11.96	-16.71 (units on a scale)*(hot flushes per day) Standard Deviation 20.60	-14.93 (units on a scale)*(hot flushes per day) Standard Deviation 16.83	-20.72 (units on a scale)*(hot flushes per day) Standard Deviation 17.81	-17.70 (units on a scale)*(hot flushes per day) Standard Deviation 15.38
Mean Change From Baseline in the Mean Daily Hot Flush Score (Frequency x Severity) at Weeks 1, 2, 4, 8, 12 and 16 Week 16: Change from baseline	-10.89 (units on a scale)*(hot flushes per day) Standard Deviation 13.45	-14.93 (units on a scale)*(hot flushes per day) Standard Deviation 25.48	-4.97 (units on a scale)*(hot flushes per day) Standard Deviation 14.35	-15.60 (units on a scale)*(hot flushes per day) Standard Deviation 19.03	-7.50 (units on a scale)*(hot flushes per day) Standard Deviation 16.55

SECONDARY outcome

Timeframe: Week 12

Population: Participants in full analysis set (FAS) with evaluable data.

The percent change from baseline at a visit Week 12 was calculated. Percent change = (change from baseline in mean daily frequency of moderate and severe hot flushes from baseline to Week 12 / Mean daily frequency of moderate and severe hot flushes at baseline) * 100. A participant was considered as a responder with a reduction of ≥50% (or ≥80%) if the percent change was ≤-50 (or ≤-80).

Outcome measures

Measure	Placebo n=44 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=30 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=16 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=51 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=43 Participants Participants received 4x40 mg elinzanetant capsules.
Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 >= 50% reduction · Yes	17 Participants	20 Participants	5 Participants	32 Participants	30 Participants
Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 >= 50% reduction · No	27 Participants	10 Participants	11 Participants	19 Participants	13 Participants
Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 >=80% reduction · Yes	8 Participants	6 Participants	0 Participants	16 Participants	18 Participants
Number of Participants With ≥50% and ≥80% Reduction From Baseline in Mean Daily Hot Flushes Frequency at Week 12 >=80% reduction · No	36 Participants	24 Participants	16 Participants	35 Participants	25 Participants

SECONDARY outcome

Timeframe: From baseline to Weeks 1, 2, 4, 8, 12 and 16

Population: Participants with available data are reported.

Participants were provided with an eDiary to document the number of night-time awakenings (NTA). Each evening, participants recorded the total number of hot flushes of each severity experienced that day since waking. Each morning upon waking, subjects recorded the number of times they woke up in the night and the total number of hot flushes of each severity experienced during the night.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 Week 16: Change from baseline	-1.08 Night-time awakenings per day Standard Deviation 1.30	-0.96 Night-time awakenings per day Standard Deviation 1.91	-0.31 Night-time awakenings per day Standard Deviation 2.90	-1.05 Night-time awakenings per day Standard Deviation 1.30	-0.32 Night-time awakenings per day Standard Deviation 2.10
Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 Baseline	3.86 Night-time awakenings per day Standard Deviation 2.06	3.44 Night-time awakenings per day Standard Deviation 1.82	5.00 Night-time awakenings per day Standard Deviation 1.76	3.80 Night-time awakenings per day Standard Deviation 2.20	3.85 Night-time awakenings per day Standard Deviation 2.57
Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 Week 1: Change from baseline	-0.65 Night-time awakenings per day Standard Deviation 1.08	-0.70 Night-time awakenings per day Standard Deviation 1.24	-0.57 Night-time awakenings per day Standard Deviation 1.57	-0.91 Night-time awakenings per day Standard Deviation 1.06	-0.86 Night-time awakenings per day Standard Deviation 1.93
Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 Week 2: Change from baseline	-0.62 Night-time awakenings per day Standard Deviation 1.54	-0.70 Night-time awakenings per day Standard Deviation 1.20	-1.09 Night-time awakenings per day Standard Deviation 1.84	-1.10 Night-time awakenings per day Standard Deviation 1.34	-1.00 Night-time awakenings per day Standard Deviation 2.10
Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 Week 4: Change from baseline	-0.86 Night-time awakenings per day Standard Deviation 1.40	-1.05 Night-time awakenings per day Standard Deviation 1.43	-0.99 Night-time awakenings per day Standard Deviation 2.96	-1.49 Night-time awakenings per day Standard Deviation 1.43	-1.03 Night-time awakenings per day Standard Deviation 2.22
Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 Week 8: Change from baseline	-0.99 Night-time awakenings per day Standard Deviation 1.31	-1.66 Night-time awakenings per day Standard Deviation 1.77	-1.30 Night-time awakenings per day Standard Deviation 2.15	-1.79 Night-time awakenings per day Standard Deviation 1.47	-1.17 Night-time awakenings per day Standard Deviation 2.51
Mean Change From Baseline in Number of All Night-time Awakenings (NTA) at Weeks 1, 2, 4, 8, 12 and 16 Week 12: Change from baseline	-1.28 Night-time awakenings per day Standard Deviation 1.44	-1.53 Night-time awakenings per day Standard Deviation 1.89	-1.61 Night-time awakenings per day Standard Deviation 2.46	-1.60 Night-time awakenings per day Standard Deviation 1.38	-1.40 Night-time awakenings per day Standard Deviation 2.40

SECONDARY outcome

Timeframe: From baseline to Weeks 1, 2, 4, 8, 12 and 16

Population: Participants in full analysis set (FAS) with evaluable data.

Subjects were provided with an eDiary to document the number of night-time awakenings (NTA). Each evening, subjects recorded the total number of hot flashes of each severity experienced that day since waking. Each morning upon waking, subjects recorded the number of times they woke up in the night and the total number of hot flushes of each severity experienced during the night. Night-time awakenings secondary to hot flashes corresponded to severe hot flash recorded on the morning diary, and all NTAs corresponded to the data recorded in the "Total number of times you woke up last night?" field from the eDiary recorded in the morning. Number of NTAs secondary to hot flushes could not be higher than the number of all NTAs.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 Baseline	2.90 Night-time awakenings per day Standard Deviation 1.64	2.41 Night-time awakenings per day Standard Deviation 1.57	4.05 Night-time awakenings per day Standard Deviation 1.86	2.76 Night-time awakenings per day Standard Deviation 1.71	2.57 Night-time awakenings per day Standard Deviation 1.54
Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 Week 1: Change from baseline	-0.57 Night-time awakenings per day Standard Deviation 0.96	-0.52 Night-time awakenings per day Standard Deviation 1.07	-0.63 Night-time awakenings per day Standard Deviation 1.53	-0.90 Night-time awakenings per day Standard Deviation 1.03	-0.68 Night-time awakenings per day Standard Deviation 1.14
Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 Week 2: Change from baseline	-0.69 Night-time awakenings per day Standard Deviation 1.03	-0.75 Night-time awakenings per day Standard Deviation 1.18	-1.13 Night-time awakenings per day Standard Deviation 1.89	-1.18 Night-time awakenings per day Standard Deviation 1.27	-0.92 Night-time awakenings per day Standard Deviation 1.38
Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 Week 4: Change from baseline	-0.89 Night-time awakenings per day Standard Deviation 1.08	-0.91 Night-time awakenings per day Standard Deviation 1.26	-1.33 Night-time awakenings per day Standard Deviation 2.27	-1.53 Night-time awakenings per day Standard Deviation 1.19	-1.01 Night-time awakenings per day Standard Deviation 1.62
Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 Week 8: Change from baseline	-1.09 Night-time awakenings per day Standard Deviation 1.36	-1.50 Night-time awakenings per day Standard Deviation 1.40	-1.69 Night-time awakenings per day Standard Deviation 2.21	-1.79 Night-time awakenings per day Standard Deviation 1.35	-1.13 Night-time awakenings per day Standard Deviation 1.86
Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 Week 12: Change from baseline	-1.31 Night-time awakenings per day Standard Deviation 1.39	-1.63 Night-time awakenings per day Standard Deviation 1.46	-1.70 Night-time awakenings per day Standard Deviation 2.53	-1.67 Night-time awakenings per day Standard Deviation 1.27	-1.32 Night-time awakenings per day Standard Deviation 1.75
Mean Change From Baseline in Mean Daily Number of NTAs Secondary to Hot Flushes at Weeks 1, 2, 4, 8, 12 and 16 Week 16: Change from baseline	-1.05 Night-time awakenings per day Standard Deviation 1.19	-1.29 Night-time awakenings per day Standard Deviation 1.63	-0.45 Night-time awakenings per day Standard Deviation 2.05	-1.19 Night-time awakenings per day Standard Deviation 1.23	-0.44 Night-time awakenings per day Standard Deviation 1.62

SECONDARY outcome

Timeframe: From baseline to Weeks 4, 8, 12 and 16

Population: Participants in full analysis set (FAS) with evaluable data. Some participants either had missing value at baseline or missing value at a specific assessment week, so the change from baseline value cannot be obtained.

The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The PSQI uses 19 individual items to generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, each scored 0 (no difficulty) to 3 (severe difficulty). The sum of scores for these seven components yields one global score (range 0 to 21). Higher scores indicated worse sleep quality.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 Baseline	10.80 Units on scale Standard Deviation 2.39	11.94 Units on scale Standard Deviation 3.11	11.35 Units on scale Standard Deviation 3.66	10.80 Units on scale Standard Deviation 3.00	11.44 Units on scale Standard Deviation 3.14
Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 Week 4: Change from baseline	-0.63 Units on scale Standard Deviation 2.02	-1.87 Units on scale Standard Deviation 2.93	-1.94 Units on scale Standard Deviation 2.68	-2.70 Units on scale Standard Deviation 3.11	-2.80 Units on scale Standard Deviation 2.84
Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 Week 8: Change from baseline	-1.36 Units on scale Standard Deviation 2.90	-2.39 Units on scale Standard Deviation 3.63	-2.38 Units on scale Standard Deviation 3.30	-3.00 Units on scale Standard Deviation 3.23	-3.14 Units on scale Standard Deviation 3.37
Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 Week 12: Change from baseline	-1.15 Units on scale Standard Deviation 2.95	-2.47 Units on scale Standard Deviation 3.82	-2.81 Units on scale Standard Deviation 2.97	-3.39 Units on scale Standard Deviation 3.12	-3.54 Units on scale Standard Deviation 4.12
Change From Baseline in the Global and Individual Domain Scores of the Pittsburgh Sleep Quality Index (PSQI) at Weeks 4, 8, 12 and 16 Week 16: Change from baseline	-1.85 Units on scale Standard Deviation 2.46	-2.10 Units on scale Standard Deviation 3.53	-1.38 Units on scale Standard Deviation 3.26	-2.24 Units on scale Standard Deviation 3.12	-1.79 Units on scale Standard Deviation 2.69

SECONDARY outcome

Timeframe: From baseline to Weeks 4, 8, 12 and 16

Population: Participants in full analysis set (FAS) with evaluable data. Some participants either had missing value at baseline or missing value at a specific assessment week, so the change from baseline value cannot be obtained.

The ISI is a brief self-report questionnaire assessing the nature, severity, and impact of insomnia. The ISI comprises seven items assessing the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Participants rated each item on a scale of 0 to 4, yielding a total score ranging from 0 to 28.

The total score was calculated by adding the scores for all seven items. Higher scores indicated severe insomnia.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 Baseline	12.43 Units on scale Standard Deviation 5.09	13.23 Units on scale Standard Deviation 5.36	13.24 Units on scale Standard Deviation 8.04	12.63 Units on scale Standard Deviation 5.66	13.74 Units on scale Standard Deviation 5.89
Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 Week 4: Change from Baseline	-1.60 Units on scale Standard Deviation 2.98	-2.74 Units on scale Standard Deviation 4.91	-3.65 Units on scale Standard Deviation 6.03	-5.14 Units on scale Standard Deviation 5.51	-5.42 Units on scale Standard Deviation 5.42
Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 Week 8: Change from Baseline	-1.51 Units on scale Standard Deviation 3.64	-3.74 Units on scale Standard Deviation 5.63	-4.44 Units on scale Standard Deviation 6.17	-6.20 Units on scale Standard Deviation 4.93	-5.72 Units on scale Standard Deviation 5.14
Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 Week 12: Change from Baseline	-1.95 Units on scale Standard Deviation 4.70	-3.80 Units on scale Standard Deviation 5.45	-5.81 Units on scale Standard Deviation 5.86	-6.12 Units on scale Standard Deviation 5.41	-7.39 Units on scale Standard Deviation 5.82
Change From Baseline in the Insomnia Severity Index (ISI) Score at Weeks 4, 8, 12 and 16 Week 16: Change from Baseline	-2.65 Units on scale Standard Deviation 4.32	-3.73 Units on scale Standard Deviation 6.02	-3.00 Units on scale Standard Deviation 3.72	-4.34 Units on scale Standard Deviation 5.58	-4.00 Units on scale Standard Deviation 5.49

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 8, 12 and 16

Population: Participants in full analysis set (FAS) with evaluable data.

The HFRDIS is a 10-item, self-report questionnaire assessing the impact of hot flushes on a woman's life during the past week. For each of the 10 items, participants rated how much hot flushes had interfered with that aspect of their life on a scale of 0 (not at all) to 10 (very much so). The total score was calculated by adding the scores for all 10 items. Higher scores indicated greater interference.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 Week 12: Change from	-19.37 Units on scale Standard Deviation 20.20	-21.30 Units on scale Standard Deviation 22.89	-15.56 Units on scale Standard Deviation 28.70	-28.33 Units on scale Standard Deviation 25.36	-27.83 Units on scale Standard Deviation 24.64
Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 Baseline	52.93 Units on scale Standard Deviation 18.40	52.74 Units on scale Standard Deviation 20.33	50.29 Units on scale Standard Deviation 21.45	53.86 Units on scale Standard Deviation 23.42	55.36 Units on scale Standard Deviation 19.71
Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 Week 2: Change from baseline	-4.00 Units on scale Standard Deviation 20.28	-5.39 Units on scale Standard Deviation 21.99	-11.12 Units on scale Standard Deviation 28.14	-13.75 Units on scale Standard Deviation 29.66	-10.90 Units on scale Standard Deviation 21.31
Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 Week 4: Change from baseline	-9.98 Units on scale Standard Deviation 20.84	-13.00 Units on scale Standard Deviation 22.53	-15.06 Units on scale Standard Deviation 24.02	-23.04 Units on scale Standard Deviation 28.32	-18.44 Units on scale Standard Deviation 23.37
Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 Week 8: Change from baseline	-15.48 Units on scale Standard Deviation 21.07	-16.26 Units on scale Standard Deviation 23.71	-17.88 Units on scale Standard Deviation 27.15	-26.39 Units on scale Standard Deviation 24.90	-24.09 Units on scale Standard Deviation 25.51
Change From Baseline in the Hot Flush Related Daily Interference Scale (HFRDIS) Scores at Weeks 2, 4, 8, 12 and 16 Week 16: Change from baseline	-15.22 Units on scale Standard Deviation 21.72	-10.73 Units on scale Standard Deviation 24.87	-16.69 Units on scale Standard Deviation 24.15	-19.16 Units on scale Standard Deviation 22.43	-12.07 Units on scale Standard Deviation 25.94

SECONDARY outcome

Timeframe: From baseline to Weeks 4, 8, 12 and 16;

Population: Participants in full analysis set (FAS) with evaluable data.

The MenQoL-I is a validated questionnaire used to measure condition-specific quality of life in menopausal women. It is composed of 32 items across four domains (physical, vasomotor, psychosocial and sexual). For each item, participants recorded whether they had experienced the problem in the past month, and if so, they rated how bothered they were by the problem on a scale of 0 (not at all bothered) to 6 (extremely bothered). The item scores were converted to a score ranging from 1 to 8.

Domain scores are calculated by averaging the converted individual item scores (range 1-8) related to the respective domain. (Domains: Vasomotor - items 1 to 3, Psychosocial - items 4 to 10, Physical- items 11- to 26, Sexual - items 27 to 29). For a MENQOL total score the aggregated mean of the mean domain scores is calculated. Higher scores indicate greater bother.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 Baseline	4.00 Units on scale Standard Deviation 1.06	4.38 Units on scale Standard Deviation 1.16	4.47 Units on scale Standard Deviation 1.25	4.17 Units on scale Standard Deviation 1.13	4.50 Units on scale Standard Deviation 1.23
Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 Week 4: Change from baseline	-0.33 Units on scale Standard Deviation 0.90	-0.62 Units on scale Standard Deviation 1.30	-0.56 Units on scale Standard Deviation 0.87	-1.29 Units on scale Standard Deviation 1.14	-1.13 Units on scale Standard Deviation 1.09
Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 Week 8: Change from baseline	-0.62 Units on scale Standard Deviation 1.10	-0.87 Units on scale Standard Deviation 1.25	-0.91 Units on scale Standard Deviation 1.06	-1.45 Units on scale Standard Deviation 1.18	-1.50 Units on scale Standard Deviation 0.99
Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 Week 12: Change from baseline	-0.70 Units on scale Standard Deviation 1.03	-0.81 Units on scale Standard Deviation 1.44	-1.09 Units on scale Standard Deviation 0.76	-1.54 Units on scale Standard Deviation 1.34	-1.72 Units on scale Standard Deviation 1.32
Change From Baseline in the Menopause-specific Quality-of-Life Questionnaire Intervention Version (MenQoL-I) Scores at Weeks 4, 8, 12 and 16 Week 16: Change from baseline	-0.68 Units on scale Standard Deviation 1.01	-0.76 Units on scale Standard Deviation 1.33	-0.69 Units on scale Standard Deviation 0.93	-1.18 Units on scale Standard Deviation 1.13	-1.00 Units on scale Standard Deviation 1.36

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 8, 12 and 16

Population: Participants in full analysis set (FAS) with evaluable data.

The BDI-II is a 21-item questionnaire assessing the intensity of depressive symptoms over the past 2 weeks. It is composed of items relating to symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex. Participants rated each item on a scale of 0 to 3 to give a total score ranging from 0 to 63, with a higher score suggesting more severe depressive symptoms.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 Baseline	11.18 Units on scale Standard Deviation 8.74	14.29 Units on scale Standard Deviation 11.36	10.47 Units on scale Standard Deviation 7.01	9.92 Units on scale Standard Deviation 8.62	11.48 Units on scale Standard Deviation 9.30
Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 Week 2: Change from baseline	-1.90 Units on scale Standard Deviation 5.29	-2.23 Units on scale Standard Deviation 9.27	-3.06 Units on scale Standard Deviation 7.34	-3.65 Units on scale Standard Deviation 6.95	-2.71 Units on scale Standard Deviation 6.08
Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 Week 4: Change from baseline	-1.55 Units on scale Standard Deviation 5.14	-4.23 Units on scale Standard Deviation 9.82	-2.35 Units on scale Standard Deviation 5.16	-4.08 Units on scale Standard Deviation 6.39	-4.13 Units on scale Standard Deviation 6.63
Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 Week 8: Change from baseline	-2.24 Units on scale Standard Deviation 5.26	-5.32 Units on scale Standard Deviation 10.13	-2.00 Units on scale Standard Deviation 8.22	-4.73 Units on scale Standard Deviation 6.34	-5.51 Units on scale Standard Deviation 7.14
Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 Week 12: Change from baseline	-1.30 Units on scale Standard Deviation 7.22	-5.00 Units on scale Standard Deviation 3.80	-1.69 Units on scale Standard Deviation 7.65	-4.29 Units on scale Standard Deviation 6.56	-5.73 Units on scale Standard Deviation 7.39
Change From Baseline in the Beck Depression Inventory II (BDI-II) Scores at Weeks 2, 4, 8, 12 and 16 Week 16: Change from baseline	-2.43 Units on scale Standard Deviation 6.08	-5.10 Units on scale Standard Deviation 11.62	-0.75 Units on scale Standard Deviation 6.71	-4.04 Units on scale Standard Deviation 6.12	-2.36 Units on scale Standard Deviation 8.05

SECONDARY outcome

Timeframe: At Weeks 2, 4, 8 ,12

Population: Participants in safety analysis set (SAF) with evaluable data.

Blood samples for analysis of plasma elinzanetant concentrations were collected at Weeks 2, 4, 8, and 12. A small number of participants had elinzanetant concentrations below the LOQ for the assay (1.5 ng/mL) at two or more visits (three participants in each of the 40 mg, 120 mg, and 160 mg groups, four in 80 mg group), indicating that these subjects were non compliant with treatment.

Outcome measures

Measure	Placebo n=31 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=17 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) Participants received 4x40 mg elinzanetant capsules.
Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 Week 2	64.254 ng/ml Geometric Coefficient of Variation 75.681 • Interval 75.681 to	157.207 ng/ml Geometric Coefficient of Variation 93.120 • Interval 93.12 to	292.929 ng/ml Geometric Coefficient of Variation 100.381 • Interval 100.381 to	319.552 ng/ml Geometric Coefficient of Variation 170.571 • Interval 170.571 to	—
Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 Week 4	78.946 ng/ml Geometric Coefficient of Variation 78.892 • Interval 78.892 to	118.554 ng/ml Geometric Coefficient of Variation 175.865 • Interval 175.865 to	253.800 ng/ml Geometric Coefficient of Variation 142.944 • Interval 142.944 to	398.389 ng/ml Geometric Coefficient of Variation 91.644 • Interval 91.644 to	—
Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 Week 8	87.985 ng/ml Geometric Coefficient of Variation 68.277 • Interval 68.277 to	138.795 ng/ml Geometric Coefficient of Variation 72.619 • Interval 72.619 to	226.121 ng/ml Geometric Coefficient of Variation 79.171 • Interval 79.171 to	341.673 ng/ml Geometric Coefficient of Variation 145.535 • Interval 145.535 to	—
Plasma Elinzanetant Concentrations at Weeks 2, 4, 8 ,12 Week 12	70.138 ng/ml Geometric Coefficient of Variation 66.542 • Interval 66.542 to	130.729 ng/ml Geometric Coefficient of Variation 414.199 • Interval 414.199 to	197.041 ng/ml Geometric Coefficient of Variation 231.390 • Interval 231.39 to	298.896 ng/ml Geometric Coefficient of Variation 220.963 • Interval 220.963 to	—

SECONDARY outcome

Timeframe: Up to Week 16

Population: Participants in safety analysis set (SAF) with evaluable data.

A Treatment-Emergent Adverse Events (TEAE) is defined as any adverse event (serious and non-serious) with the onset date on or after the date of first dosing with study treatment. Safety Analysis Set.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Nature and Severity of Adverse Events Number of TEAEs	28 Participants	17 Participants	14 Participants	34 Participants	38 Participants
Nature and Severity of Adverse Events Number of TEAEs related to IMP	7 Participants	7 Participants	8 Participants	8 Participants	12 Participants
Nature and Severity of Adverse Events Number of Serious TEAEs	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Nature and Severity of Adverse Events Number of TEAEs leading to death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Nature and Severity of Adverse Events Number of Severe TEAEs	2 Participants	0 Participants	1 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Week 16

Population: Participants in safety analysis set (SAF) with evaluable data.

A Treatment-Emergent Adverse Events (TEAE) is defined as any adverse event (serious and non-serious) with the onset date on or after the date of first dosing with study treatment.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Withdrawals Due to an Adverse Event TEAEs leading to treatment discontinuation	1 Participants	0 Participants	2 Participants	0 Participants	5 Participants
Withdrawals Due to an Adverse Event TEAEs leading to study discontinuation	1 Participants	0 Participants	1 Participants	0 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to Week 16

Population: Participants in safety analysis set (SAF) with evaluable data.

A concomitant medication is defined as any medication used on or after date and time of first randomised treatment. All concomitant medications taken during the study were recorded in the eCRF. Any medication that was not specifically prohibited was allowed. (1) Antidiarrheals, intestinal antiinflammatory/antiinfective agents.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Number of Subjects Used Concomitant Medications Analgesics	18 Participants	8 Participants	9 Participants	12 Participants	16 Participants
Number of Subjects Used Concomitant Medications Antiinflammatory and antirheumatic products	14 Participants	7 Participants	5 Participants	12 Participants	13 Participants
Number of Subjects Used Concomitant Medications Vitamins	14 Participants	6 Participants	6 Participants	9 Participants	14 Participants
Number of Subjects Used Concomitant Medications Drugs for acid related disorders	13 Participants	7 Participants	2 Participants	10 Participants	10 Participants
Number of Subjects Used Concomitant Medications Psychoanaleptics	6 Participants	5 Participants	4 Participants	10 Participants	9 Participants
Number of Subjects Used Concomitant Medications Psycholeptics	3 Participants	7 Participants	5 Participants	7 Participants	7 Participants
Number of Subjects Used Concomitant Medications Antibacterials for systemic use	9 Participants	5 Participants	2 Participants	5 Participants	7 Participants
Number of Subjects Used Concomitant Medications Drugs for obstructive airway diseases	7 Participants	3 Participants	3 Participants	4 Participants	9 Participants
Number of Subjects Used Concomitant Medications Lipid modifying agents	3 Participants	3 Participants	4 Participants	8 Participants	4 Participants
Number of Subjects Used Concomitant Medications Agents acting on the renin-angiotensin system	7 Participants	4 Participants	0 Participants	11 Participants	3 Participants
Number of Subjects Used Concomitant Medications Thyroid therapy	4 Participants	3 Participants	3 Participants	7 Participants	5 Participants
Number of Subjects Used Concomitant Medications Antihistamines for systemic use	5 Participants	4 Participants	3 Participants	6 Participants	3 Participants
Number of Subjects Used Concomitant Medications Antithrombotic agents	2 Participants	4 Participants	2 Participants	6 Participants	4 Participants
Number of Subjects Used Concomitant Medications Nasal preparations	2 Participants	4 Participants	1 Participants	1 Participants	7 Participants
Number of Subjects Used Concomitant Medications Diuretics	1 Participants	2 Participants	0 Participants	5 Participants	5 Participants
Number of Subjects Used Concomitant Medications Antianemic preparations	5 Participants	2 Participants	2 Participants	5 Participants	2 Participants
Number of Subjects Used Concomitant Medications Mineral supplements	2 Participants	2 Participants	3 Participants	3 Participants	3 Participants
Number of Subjects Used Concomitant Medications Calcium channel blockers	3 Participants	0 Participants	1 Participants	6 Participants	3 Participants
Number of Subjects Used Concomitant Medications Drugs used in diabetes	3 Participants	2 Participants	0 Participants	1 Participants	6 Participants
Number of Subjects Used Concomitant Medications Beta blocking agents	1 Participants	2 Participants	0 Participants	5 Participants	1 Participants
Number of Subjects Used Concomitant Medications Ophthalmologicals	1 Participants	1 Participants	2 Participants	3 Participants	1 Participants
Number of Subjects Used Concomitant Medications Urologicals	1 Participants	1 Participants	1 Participants	3 Participants	1 Participants
Number of Subjects Used Concomitant Medications Antidiarrheals, intestinal agents (1)	2 Participants	2 Participants	0 Participants	0 Participants	3 Participants
Number of Subjects Used Concomitant Medications Antivirals for systemic use	1 Participants	3 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects Used Concomitant Medications Corticosteroids for systemic use	1 Participants	1 Participants	0 Participants	1 Participants	3 Participants
Number of Subjects Used Concomitant Medications Drugs for constipation	2 Participants	0 Participants	1 Participants	3 Participants	1 Participants
Number of Subjects Used Concomitant Medications Anesthetics	2 Participants	1 Participants	0 Participants	3 Participants	0 Participants
Number of Subjects Used Concomitant Medications Antiemetics and antinauseants	2 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects Used Concomitant Medications Drugs for functional gastrointestinal disorders	3 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects Used Concomitant Medications General nutrients	1 Participants	1 Participants	0 Participants	1 Participants	2 Participants
Number of Subjects Used Concomitant Medications Topical products for joint and muscular pain	1 Participants	2 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects Used Concomitant Medications Antifungals for dermatological use	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects Used Concomitant Medications Antiobesity preparations, excl. Diet products	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants
Number of Subjects Used Concomitant Medications Corticosteroids, dermatological preparations	1 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Used Concomitant Medications Cough and cold preparations	3 Participants	1 Participants	0 Participants	2 Participants	0 Participants
Number of Subjects Used Concomitant Medications Other nervous system drugs	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects Used Concomitant Medications Unspecified herbal and traditional medicine	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Subjects Used Concomitant Medications All other therapeutic products	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Used Concomitant Medications Anti-acne preparations	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Used Concomitant Medications Other alimentary tract and metabolism products	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Used Concomitant Medications Throat preparations	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Used Concomitant Medications Vaccines	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Used Concomitant Medications Antiepileptics	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects Used Concomitant Medications Antihemorrhagics	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Used Concomitant Medications Antipruritics, incl. antihistamines, anesthetics	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Used Concomitant Medications Antipsoriatics	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Used Concomitant Medications Antihypertensives	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects Used Concomitant Medications Antiprotozoals	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Used Concomitant Medications Bile and liver therapy	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Used Concomitant Medications Drugs for treatment of bone diseases	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects Used Concomitant Medications Gynecological antiinfectives and antiseptics	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Used Concomitant Medications Immunosuppressants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Used Concomitant Medications Other respiratory system products	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Used Concomitant Medications Stomatological preparations	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects Used Concomitant Medications Tonics	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Used Concomitant Medications Muscle relaxants	2 Participants	0 Participants	1 Participants	1 Participants	2 Participants
Number of Subjects Used Concomitant Medications Antibiotics,chemotherapeutics (dermatological use)	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects Used Concomitant Medications Antimycotics for systemic use	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 Baseline	123.2 mmHg Standard Deviation 10.4	124.2 mmHg Standard Deviation 10.1	128.9 mmHg Standard Deviation 9.8	124.6 mmHg Standard Deviation 10.9	124.0 mmHg Standard Deviation 12.9
Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 Week 2: Change from baseline	0.3 mmHg Standard Deviation 12.5	-0.2 mmHg Standard Deviation 9.0	-1.5 mmHg Standard Deviation 12.5	-2.9 mmHg Standard Deviation 9.3	-0.8 mmHg Standard Deviation 9.2
Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 Week 4: Change from baseline	1.7 mmHg Standard Deviation 12.4	0.1 mmHg Standard Deviation 11.9	-3.1 mmHg Standard Deviation 9.4	-4.7 mmHg Standard Deviation 10.7	-1.3 mmHg Standard Deviation 10.8
Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 Week 8: Change from baseline	0.5 mmHg Standard Deviation 10.8	0.5 mmHg Standard Deviation 12.5	-2.1 mmHg Standard Deviation 10.1	-1.3 mmHg Standard Deviation 10.0	-3.8 mmHg Standard Deviation 10.5
Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 Week 12: Change from baseline	-0.6 mmHg Standard Deviation 12.2	-2.1 mmHg Standard Deviation 10.9	-5.9 mmHg Standard Deviation 11.3	-1.1 mmHg Standard Deviation 10.2	-1.3 mmHg Standard Deviation 12.8
Change From Baseline in Vital Signs (Systolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 Week 16: Change from baseline	3.8 mmHg Standard Deviation 13.3	-0.9 mmHg Standard Deviation 11.7	-6.4 mmHg Standard Deviation 11.1	-1.4 mmHg Standard Deviation 10.8	2.1 mmHg Standard Deviation 9.4

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Vital signs, including systolic and diastolic blood pressure were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 Baseline	80.1 mmHg Standard Deviation 8.0	78.7 mmHg Standard Deviation 8.5	79.9 mmHg Standard Deviation 9.1	78.1 mmHg Standard Deviation 7.6	78.7 mmHg Standard Deviation 10.1
Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 Week 2: Change from baseline	-0.7 mmHg Standard Deviation 6.6	-1.1 mmHg Standard Deviation 8.4	-0.8 mmHg Standard Deviation 8.7	-3.1 mmHg Standard Deviation 7.6	-0.4 mmHg Standard Deviation 7.6
Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 Week 4: Change from baseline	-0.2 mmHg Standard Deviation 7.4	1.2 mmHg Standard Deviation 7.8	-2.1 mmHg Standard Deviation 6.5	-2.8 mmHg Standard Deviation 9.1	-2.3 mmHg Standard Deviation 8.0
Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 Week 8: Change from baseline	0.2 mmHg Standard Deviation 6.7	-0.5 mmHg Standard Deviation 6.8	-3.6 mmHg Standard Deviation 6.9	-0.6 mmHg Standard Deviation 8.4	-1.6 mmHg Standard Deviation 7.5
Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 Week 12: Change from baseline	-0.5 mmHg Standard Deviation 9.6	-2.8 mmHg Standard Deviation 9.9	-2.2 mmHg Standard Deviation 7.1	-1.8 mmHg Standard Deviation 10.3	-1.0 mmHg Standard Deviation 9.3
Change From Baseline in Vital Signs (Diastolic Blood Pressure) at Weeks 2, 4, 8, 12 and 16 Week 16: Change from baseline	1.6 mmHg Standard Deviation 7.6	-1.2 mmHg Standard Deviation 8.3	-3.8 mmHg Standard Deviation 9.7	-1.9 mmHg Standard Deviation 9.1	0.6 mmHg Standard Deviation 7.2

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 Baseline	69.7 beats/min Standard Deviation 7.8	71.4 beats/min Standard Deviation 10.3	70.6 beats/min Standard Deviation 8.7	70.1 beats/min Standard Deviation 10.2	69.7 beats/min Standard Deviation 10.2
Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 Week 2: Change from baseline	-0.1 beats/min Standard Deviation 8.1	-0.3 beats/min Standard Deviation 7.3	-0.7 beats/min Standard Deviation 9.9	-3.1 beats/min Standard Deviation 9.7	2.1 beats/min Standard Deviation 9.4
Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 Week 4: Change from baseline	-0.6 beats/min Standard Deviation 6.9	0.5 beats/min Standard Deviation 7.6	-2.8 beats/min Standard Deviation 8.9	-1.8 beats/min Standard Deviation 6.4	0.9 beats/min Standard Deviation 7.7
Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 Week 8: Change from baseline	0.4 beats/min Standard Deviation 7.7	-0.5 beats/min Standard Deviation 8.1	-3.1 beats/min Standard Deviation 9.8	-2.8 beats/min Standard Deviation 7.9	0.3 beats/min Standard Deviation 8.1
Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 Week 12: Change from baseline	0.1 beats/min Standard Deviation 9.2	0.3 beats/min Standard Deviation 8.4	0.9 beats/min Standard Deviation 8.8	-1.4 beats/min Standard Deviation 8.8	0.9 beats/min Standard Deviation 7.4
Change From Baseline in Vital Signs (Pulse Rate) at Weeks 2, 4, 8, 12 and 16 Week 16: Change from baseline	3.2 beats/min Standard Deviation 10.6	3.3 beats/min Standard Deviation 10.5	0.0 beats/min Standard Deviation 11.3	-0.7 beats/min Standard Deviation 8.5	0.3 beats/min Standard Deviation 8.4

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 Baseline	36.69 Celsius (C) Standard Deviation 0.43	36.62 Celsius (C) Standard Deviation 0.32	36.73 Celsius (C) Standard Deviation 0.30	36.52 Celsius (C) Standard Deviation 0.46	36.68 Celsius (C) Standard Deviation 0.39
Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 Week 2: Change from baseline	-0.09 Celsius (C) Standard Deviation 0.40	-0.04 Celsius (C) Standard Deviation 0.28	0.04 Celsius (C) Standard Deviation 0.26	0.12 Celsius (C) Standard Deviation 0.50	-0.01 Celsius (C) Standard Deviation 0.43
Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 Week 4: Change from baseline	-0.15 Celsius (C) Standard Deviation 0.47	-0.06 Celsius (C) Standard Deviation 0.34	0.01 Celsius (C) Standard Deviation 0.41	0.12 Celsius (C) Standard Deviation 0.46	-0.06 Celsius (C) Standard Deviation 0.32
Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 Week 8: Change from baseline	-0.09 Celsius (C) Standard Deviation 0.38	-0.01 Celsius (C) Standard Deviation 0.35	0.00 Celsius (C) Standard Deviation 0.31	0.11 Celsius (C) Standard Deviation 0.49	-0.01 Celsius (C) Standard Deviation 0.42
Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 Week 12: Change from baseline	-0.12 Celsius (C) Standard Deviation 0.44	-0.12 Celsius (C) Standard Deviation 0.31	-0.03 Celsius (C) Standard Deviation 0.38	0.04 Celsius (C) Standard Deviation 0.46	-0.08 Celsius (C) Standard Deviation 0.36
Change From Baseline in Vital Signs (Temperature) at Weeks 2, 4, 8, 12 and 16 Week 16: Change from baseline	-0.07 Celsius (C) Standard Deviation 0.50	-0.03 Celsius (C) Standard Deviation 0.30	-0.04 Celsius (C) Standard Deviation 0.32	0.08 Celsius (C) Standard Deviation 0.41	-0.09 Celsius (C) Standard Deviation 0.41

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 Baseline	75.85 Kilogram (Kg) Standard Deviation 13.13	72.65 Kilogram (Kg) Standard Deviation 14.76	78.14 Kilogram (Kg) Standard Deviation 15.75	72.36 Kilogram (Kg) Standard Deviation 15.26	74.11 Kilogram (Kg) Standard Deviation 15.02
Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 Week 2: Change from baseline	0.20 Kilogram (Kg) Standard Deviation 1.07	0.30 Kilogram (Kg) Standard Deviation 1.03	0.13 Kilogram (Kg) Standard Deviation 1.32	-0.13 Kilogram (Kg) Standard Deviation 1.19	0.04 Kilogram (Kg) Standard Deviation 0.84
Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 Week 4: Change from baseline	0.23 Kilogram (Kg) Standard Deviation 1.51	0.08 Kilogram (Kg) Standard Deviation 1.11	0.12 Kilogram (Kg) Standard Deviation 1.88	-0.31 Kilogram (Kg) Standard Deviation 1.26	0.00 Kilogram (Kg) Standard Deviation 1.35
Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 Week 8: Change from baseline	0.16 Kilogram (Kg) Standard Deviation 1.98	0.26 Kilogram (Kg) Standard Deviation 1.59	-0.11 Kilogram (Kg) Standard Deviation 1.79	-0.18 Kilogram (Kg) Standard Deviation 1.78	-0.25 Kilogram (Kg) Standard Deviation 2.32
Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 Week 12: Change from baseline	-0.02 Kilogram (Kg) Standard Deviation 2.34	0.58 Kilogram (Kg) Standard Deviation 2.46	-0.14 Kilogram (Kg) Standard Deviation 2.03	-0.08 Kilogram (Kg) Standard Deviation 1.93	-0.48 Kilogram (Kg) Standard Deviation 2.62
Change From Baseline in Vital Signs (Weight) at Weeks 2, 4, 8, 12 and 16 Week 16: Change from baseline	0.17 Kilogram (Kg) Standard Deviation 2.48	0.39 Kilogram (Kg) Standard Deviation 2.81	-0.13 Kilogram (Kg) Standard Deviation 2.59	-0.20 Kilogram (Kg) Standard Deviation 2.13	-0.34 Kilogram (Kg) Standard Deviation 2.82

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 Baseline	28.59 kg/m^2 Standard Deviation 3.81	27.69 kg/m^2 Standard Deviation 4.97	29.81 kg/m^2 Standard Deviation 4.93	27.26 kg/m^2 Standard Deviation 4.85	27.72 kg/m^2 Standard Deviation 4.74
Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 Week 2: Change from baseline	0.07 kg/m^2 Standard Deviation 0.41	0.11 kg/m^2 Standard Deviation 0.39	0.06 kg/m^2 Standard Deviation 0.5	-0.04 kg/m^2 Standard Deviation 0.45	0.01 kg/m^2 Standard Deviation 0.33
Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 Week 4: Change from baseline	0.07 kg/m^2 Standard Deviation 0.58	0.02 kg/m^2 Standard Deviation 0.42	0.06 kg/m^2 Standard Deviation 0.75	-0.11 kg/m^2 Standard Deviation 0.49	0.00 kg/m^2 Standard Deviation 0.53
Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 Week 8: Change from baseline	0.04 kg/m^2 Standard Deviation 0.75	0.09 kg/m^2 Standard Deviation 0.59	-0.04 kg/m^2 Standard Deviation 0.69	-0.06 kg/m^2 Standard Deviation 0.66	-0.09 kg/m^2 Standard Deviation 0.88
Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 Week 12: Change from baseline	-0.03 kg/m^2 Standard Deviation 0.87	0.21 kg/m^2 Standard Deviation 0.87	-0.05 kg/m^2 Standard Deviation 0.79	-0.02 kg/m^2 Standard Deviation 0.73	-0.18 kg/m^2 Standard Deviation 0.99
Change From Baseline in Vital Signs (Body Mass Index ) at Weeks 2, 4, 8, 12 and 16 Week 16: Change from baseline	0.04 kg/m^2 Standard Deviation 0.96	0.13 kg/m^2 Standard Deviation 1.01	-0.04 kg/m^2 Standard Deviation 1.01	-0.07 kg/m^2 Standard Deviation 0.79	-0.13 kg/m^2 Standard Deviation 1.07

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Vital signs, including systolic and diastolic blood pressure, pulse rate, temperature, weight, waist circumference, and height, were measured at the time points and recorded in the eCRF. All vital signs were reviewed by the Investigator or delegated physician.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 Baseline	95.47 cm Standard Deviation 11.69	93.61 cm Standard Deviation 13.10	97.59 cm Standard Deviation 13.15	91.12 cm Standard Deviation 13.03	92.42 cm Standard Deviation 12.36
Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 Week 2: Change from baseline	0.26 cm Standard Deviation 3.99	0.79 cm Standard Deviation 3.55	-0.91 cm Standard Deviation 2.15	0.13 cm Standard Deviation 3.72	-0.18 cm Standard Deviation 3.90
Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 Week 4: Change from baseline	0.17 cm Standard Deviation 4.99	-0.07 cm Standard Deviation 4.23	-1.26 cm Standard Deviation 3.00	0.05 cm Standard Deviation 3.84	-0.09 cm Standard Deviation 3.97
Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 Week 8: Change from baseline	-0.14 cm Standard Deviation 4.45	-0.11 cm Standard Deviation 4.30	0.04 cm Standard Deviation 2.77	-0.76 cm Standard Deviation 4.10	-0.08 cm Standard Deviation 4.71
Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 Week 12: Change from baseline	-1.72 cm Standard Deviation 5.25	-1.16 cm Standard Deviation 4.87	0.60 cm Standard Deviation 2.81	-0.25 cm Standard Deviation 3.97	-0.39 cm Standard Deviation 4.42
Change From Baseline in Vital Signs (Waist Circumference) at Weeks 2, 4, 8, 12 and 16 Week 16: Change from baseline	-0.80 cm Standard Deviation 5.46	-0.99 cm Standard Deviation 5.18	4.33 cm Standard Deviation 12.90	0.02 cm Standard Deviation 4.58	-0.24 cm Standard Deviation 4.41

SECONDARY outcome

Timeframe: At Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reported results are cardiovascular system-examination findings. Normal ECG was decided by investigator. The findings are presented as Normal ECG.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit Week 16	27 Participants	26 Participants	14 Participants	31 Participants	28 Participants
Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit Baseline	38 Participants	24 Participants	11 Participants	31 Participants	34 Participants
Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit Week 2	33 Participants	23 Participants	12 Participants	34 Participants	27 Participants
Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit Week 4	32 Participants	23 Participants	10 Participants	28 Participants	31 Participants
Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit Week 8	29 Participants	21 Participants	12 Participants	30 Participants	27 Participants
Number of Subjects With Normal Electrocardiogram (ECG) Findings at Each Visit Week 12	30 Participants	22 Participants	11 Participants	31 Participants	31 Participants

SECONDARY outcome

Timeframe: At Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reported results are cardiovascular system-examination findings. Abnormal not clinically significant ECG findings were decided by investigator. The findings are presented as Abnormal not clinically significant ECG.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit Baseline	9 Participants	7 Participants	6 Participants	21 Participants	18 Participants
Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit Week 2	11 Participants	8 Participants	5 Participants	18 Participants	24 Participants
Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit Week 4	13 Participants	8 Participants	6 Participants	23 Participants	17 Participants
Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit Week 8	15 Participants	10 Participants	5 Participants	21 Participants	19 Participants
Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit Week 12	14 Participants	8 Participants	5 Participants	19 Participants	14 Participants
Number of Subjects With Abnormal Not Clinically Significant ECG Findings at Each Visit Week 16	16 Participants	4 Participants	2 Participants	20 Participants	17 Participants

SECONDARY outcome

Timeframe: At Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reported results are cardiovascular system-examination findings. Abnormal clinically significant ECG findings were decided by investigator. The findings are presented as Abnormal clinically significant ECG.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit Baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit Week 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit Week 4	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit Week 8	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit Week 12	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Abnormal Clinically Significant ECG Findings at Each Visit Week 16	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. The same model of ECG recorder was used throughout the study for any given subject wherever possible. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reports were then filed with the subject's medical record. In categories the number of subjects analyzed (N) for each week is mentioned for each reporting group respectively.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) Baseline	913.5 mSec Standard Deviation 128.5	891.4 mSec Standard Deviation 145.6	934.3 mSec Standard Deviation 120.3	927.8 mSec Standard Deviation 135.5	935.9 mSec Standard Deviation 151.2
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) Week 2: Change from baseline	17.3 mSec Standard Deviation 84.2	23.0 mSec Standard Deviation 101.7	-12.6 mSec Standard Deviation 99.7	27.3 mSec Standard Deviation 94.7	-2.6 mSec Standard Deviation 137.7
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) Week 4: Change from baseline	1.6 mSec Standard Deviation 82.8	24.8 mSec Standard Deviation 101.9	20.5 mSec Standard Deviation 108.5	27.3 mSec Standard Deviation 92.6	4.5 mSec Standard Deviation 108.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) Week 8: Change from baseline )	35.8 mSec Standard Deviation 108.7	24.8 mSec Standard Deviation 104.6	19.0 mSec Standard Deviation 128.6	22.3 mSec Standard Deviation 109.2	-22.6 mSec Standard Deviation 90.1
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) Week 12: Change from baseline	25.5 mSec Standard Deviation 143.4	18.0 mSec Standard Deviation 110.9	-23.3 mSec Standard Deviation 105.1	27.2 mSec Standard Deviation 95.9	-1.4 mSec Standard Deviation 107.9
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (RR) Week 16: Change from baseline	-22.4 mSec Standard Deviation 135.5	2.4 mSec Standard Deviation 138.5	-25.4 mSec Standard Deviation 149.6	5.9 mSec Standard Deviation 110.8	-8.0 mSec Standard Deviation 110.3

SECONDARY outcome

Timeframe: At Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. The same model of ECG recorder was used throughout the study for any given subject wherever possible. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reports were then filed with the subject's medical record.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) Baseline	162.6 mSec Standard Deviation 21.8	167.8 mSec Standard Deviation 16.5	162.9 mSec Standard Deviation 21.7	157.2 mSec Standard Deviation 21.7	164.2 mSec Standard Deviation 25.8
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) Week 2: Change from baseline	1.2 mSec Standard Deviation 9.7	4.6 mSec Standard Deviation 11.7	5.2 mSec Standard Deviation 11.8	3.0 mSec Standard Deviation 10.2	-2.2 mSec Standard Deviation 16.3
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) Week 4: Change from baseline	0.0 mSec Standard Deviation 11.2	5.9 mSec Standard Deviation 12.3	2.9 mSec Standard Deviation 12.1	3.8 mSec Standard Deviation 17.7	1.8 mSec Standard Deviation 13.8
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) Week 8: Change from baseline	1.5 mSec Standard Deviation 15.1	3.6 mSec Standard Deviation 10.4	-0.1 mSec Standard Deviation 12.3	4.3 mSec Standard Deviation 10.3	-1.1 mSec Standard Deviation 14.5
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) Week 12: Change from baseline	1.6 mSec Standard Deviation 11.5	3.9 mSec Standard Deviation 11.7	0.7 mSec Standard Deviation 16.2	1.9 mSec Standard Deviation 11.4	-1.5 mSec Standard Deviation 16.9
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (PR) Week 16: Change from baseline	0.4 mSec Standard Deviation 11.3	2.2 mSec Standard Deviation 13.3	2.4 mSec Standard Deviation 16.0	2.8 mSec Standard Deviation 11.1	-0.4 mSec Standard Deviation 13.3

SECONDARY outcome

Timeframe: At Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. The same model of ECG recorder was used throughout the study for any given subject wherever possible. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reports were then filed with the subject's medical record.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) Baseline	394.5 mSec Standard Deviation 31.2	397.2 mSec Standard Deviation 28.7	403.5 mSec Standard Deviation 26.9	402.3 mSec Standard Deviation 40.3	401.2 mSec Standard Deviation 28.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) Week 2: Change from baseline	3.6 mSec Standard Deviation 18.0	0.2 mSec Standard Deviation 17.8	1.1 mSec Standard Deviation 21.7	-0.9 mSec Standard Deviation 35.6	-3.2 mSec Standard Deviation 25.2
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) Week 4: Change from baseline	4.7 mSec Standard Deviation 18.5	-0.1 mSec Standard Deviation 18.5	4.8 mSec Standard Deviation 35.2	0.2 mSec Standard Deviation 28.1	0.8 mSec Standard Deviation 21.5
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) Week 8: Change from baseline	2.0 mSec Standard Deviation 19.0	1.5 mSec Standard Deviation 17.2	6.5 mSec Standard Deviation 28.4	0.5 mSec Standard Deviation 34.6	-4.0 mSec Standard Deviation 20.3
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) Week 12: Change from baseline	1.4 mSec Standard Deviation 25.1	0.8 mSec Standard Deviation 21.6	-8.9 mSec Standard Deviation 20.6	-1.1 mSec Standard Deviation 32.9	1.0 mSec Standard Deviation 19.5
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QT) Week 16: Change from baseline	-1.7 mSec Standard Deviation 23.3	-4.7 mSec Standard Deviation 24.4	-3.2 mSec Standard Deviation 27.6	-4.1 mSec Standard Deviation 38.1	-2.4 mSec Standard Deviation 25.5

SECONDARY outcome

Timeframe: At Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. The same model of ECG recorder was used throughout the study for any given subject wherever possible. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reports were then filed with the subject's medical record. QTc: QT corrected interval.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) Baseline	410.6 mSec Standard Deviation 20.9	417.9 mSec Standard Deviation 21.4	416.4 mSec Standard Deviation 14.1	415.9 mSec Standard Deviation 29.3	415.2 mSec Standard Deviation 22.1
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) Week 2: Change from baseline	1.6 mSec Standard Deviation 14.3	-2.4 mSec Standard Deviation 11.2	2.9 mSec Standard Deviation 14.7	-4.9 mSec Standard Deviation 28.2	-2.1 mSec Standard Deviation 15.4
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) Week 4: Change from baseline	5.6 mSec Standard Deviation 16.1	-5.4 mSec Standard Deviation 11.8	1.7 mSec Standard Deviation 19.9	-2.9 mSec Standard Deviation 24.5	0.2 mSec Standard Deviation 16.3
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) Week 8: Change from baseline	-3.9 mSec Standard Deviation 18.5	-3.8 mSec Standard Deviation 12.3	2.3 mSec Standard Deviation 10.8	-2.2 mSec Standard Deviation 27.5	1.2 mSec Standard Deviation 14.7
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) Week 12: Change from baseline	-2.4 mSec Standard Deviation 20.8	-3.2 mSec Standard Deviation 14.9	-3.1 mSec Standard Deviation 14.4	-4.7 mSec Standard Deviation 31.3	0.5 mSec Standard Deviation 14.4
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTc) Week 16: Change from baseline	2.8 mSec Standard Deviation 14.9	-4.8 mSec Standard Deviation 13.6	4.3 mSec Standard Deviation 17.5	-4.5 mSec Standard Deviation 31.2	-1.6 mSec Standard Deviation 13.6

SECONDARY outcome

Timeframe: At Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

All ECGs were performed after the subject had rested for 5 minutes in a semi-recumbent position. The same model of ECG recorder was used throughout the study for any given subject wherever possible. All ECG reports were reviewed, signed and dated by the Investigator or delegated physician. Reports were then filed with the subject's medical record. QTcF: QT interval with Fridericia's correction.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) Baseline	407.2 mSec Standard Deviation 20.6	413.8 mSec Standard Deviation 19.9	413.2 mSec Standard Deviation 14.3	413.1 mSec Standard Deviation 30.7	411.4 mSec Standard Deviation 18.6
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) Week 2: Change from baseline	1.2 mSec Standard Deviation 13.7	-3.5 mSec Standard Deviation 10.2	3.4 mSec Standard Deviation 13.4	-4.8 mSec Standard Deviation 29.5	-2.5 mSec Standard Deviation 15.7
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) Week 4: Change from baseline	4.8 mSec Standard Deviation 16.4	-4.2 mSec Standard Deviation 11.5	2.1 mSec Standard Deviation 23.4	-3.5 mSec Standard Deviation 24.7	0.4 mSec Standard Deviation 15.4
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) Week 8: Change from baseline	-2.8 mSec Standard Deviation 15.9	-2.7 mSec Standard Deviation 10.9	4.0 mSec Standard Deviation 13.2	-2.6 mSec Standard Deviation 28.7	-0.4 mSec Standard Deviation 16.1
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) Week 12: Change from baseline	-1.7 mSec Standard Deviation 18.5	-1.9 mSec Standard Deviation 13.9	-5.1 mSec Standard Deviation 13.2	-5.1 mSec Standard Deviation 30.8	1.1 mSec Standard Deviation 14.6
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in ECG Intervals (QTcF) Week 16: Change from baseline	2.6 mSec Standard Deviation 15.1	-5.6 mSec Standard Deviation 14.2	1.5 mSec Standard Deviation 14.5	-4.8 mSec Standard Deviation 32.7	-1.3 mSec Standard Deviation 16.4

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Absolute QTcF values reported.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Baseline: missing	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Baseline: <=450 msec	46 Participants	30 Participants	16 Participants	51 Participants	50 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Baseline: >450 to <=480 msec	1 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Baseline: >480 to <=500 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Baseline: >500 msec	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 2: missing	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 2: <=450 msec	44 Participants	30 Participants	16 Participants	52 Participants	50 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 2: >450 to <=480 msec	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 2: >480 to <=500 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 2: >500 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 4: missing	2 Participants	0 Participants	0 Participants	1 Participants	4 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 4: <=450 msec	44 Participants	30 Participants	16 Participants	51 Participants	47 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 4: >450 to <=480 msec	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 4: >480 to <=500 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 4: >500 msec	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 8: missing	3 Participants	0 Participants	0 Participants	0 Participants	6 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 8: <=450 msec	44 Participants	30 Participants	17 Participants	52 Participants	46 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 8: >450 to <=480 msec	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 8: >480 to <=500 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 8: >500 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 12: missing	3 Participants	1 Participants	1 Participants	2 Participants	7 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 12: <=450 msec	44 Participants	30 Participants	16 Participants	50 Participants	45 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 12: >450 to <=480 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 12: >480 to <=500 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 12: >500 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 16: missing	4 Participants	1 Participants	1 Participants	1 Participants	7 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 16: <=450 msec	42 Participants	30 Participants	15 Participants	51 Participants	44 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 16: >450 to <=480 msec	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 16: >480 to <=500 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Absolute QTcF Values by Category at Each Visit: ≤450, >450 to ≤480, >480 to ≤500, >500 Msec Week 16: >500 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Increase from Baseline overtime was reported.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 16: <=0 msec	18 Participants	18 Participants	7 Participants	26 Participants	24 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 2: missing	3 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 2: <=0 msec	19 Participants	21 Participants	8 Participants	27 Participants	29 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 2: >0 to <=30 msec	25 Participants	10 Participants	8 Participants	24 Participants	22 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 2: >30 to <=60 msec	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 2: >60 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 4: missing	2 Participants	0 Participants	0 Participants	1 Participants	4 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 4: <=0 msec	20 Participants	20 Participants	8 Participants	27 Participants	24 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 4: >0 to <=30 msec	23 Participants	11 Participants	8 Participants	24 Participants	22 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 4: >30 to <=60 msec	2 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 4: >60 msec	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 8: missing	3 Participants	0 Participants	0 Participants	0 Participants	6 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 8: <=0 msec	24 Participants	20 Participants	8 Participants	25 Participants	19 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 8: >0 to <=30 msec	20 Participants	11 Participants	9 Participants	26 Participants	26 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 8: >30 to <=60 msec	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 8: >60 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 12: missing	3 Participants	1 Participants	1 Participants	2 Participants	7 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 12: <=0 msec	24 Participants	15 Participants	10 Participants	29 Participants	22 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 12: >0 to <=30 msec	19 Participants	15 Participants	6 Participants	21 Participants	22 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 12: >30 to <=60 msec	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 12: >60 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 16: missing	4 Participants	1 Participants	1 Participants	1 Participants	7 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 16: >0 to <=30 msec	23 Participants	12 Participants	9 Participants	24 Participants	20 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 16: >30 to <=60 msec	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Subjects With Change From Baseline in ECG QTcF Values by Category at Weeks 2, 4, 8, 12 and 16: ≤0, >0 to ≤30, >30 to ≤60, >60 Msec Week 16: >60 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline to Weeks 4, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

The Columbia Suicide Severity Rating Scale (C-SSRS) is a rating scale created to evaluate suicidality in adults and children over the age of 12. It rates an individual's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The version used was the eC-SSRS, which is a subject-reported version of the scale. Shifts from baseline versus post-baseline to demonstrate changes in categories (cat) were reported using cat 1 (No Suicidal Ideation or Behaviour), cat 2 (Suicidal Ideation) and cat 3 (Suicidal Behaviour).

Outcome measures

Measure	Placebo n=42 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=27 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=16 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=46 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=46 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 4: shift from cat 1 to cat 1	34 Participants	14 Participants	13 Participants	38 Participants	38 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 4: shift from cat 1 to cat 2	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 4: shift from cat 1 to cat 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 4: shift from cat 2 to cat 1	5 Participants	7 Participants	2 Participants	4 Participants	7 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 4: shift from cat 2 to cat 2	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 4: shift from cat 2 to cat 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 4: shift from cat 3 to cat 1	1 Participants	5 Participants	1 Participants	2 Participants	1 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 4: shift from cat 3 to cat 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 4: shift from cat 3 to cat 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 12: shift from cat 1 to cat 1	34 Participants	14 Participants	12 Participants	40 Participants	33 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 12: shift from cat 1 to cat 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 12: shift from cat 1 to cat 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 12: shift from cat 2 to cat 1	7 Participants	5 Participants	3 Participants	2 Participants	7 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 12: shift from cat 2 to cat 2	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 12: shift from cat 2 to cat 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 12: shift from cat 3 to cat 1	1 Participants	5 Participants	1 Participants	2 Participants	1 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 12: shift from cat 3 to cat 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 12: shift from cat 3 to cat 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 16: shift from cat 1 to cat 1	33 Participants	15 Participants	12 Participants	40 Participants	33 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 16: shift from cat 1 to cat 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 16: shift from cat 1 to cat 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 16: shift from cat 2 to cat 1	6 Participants	6 Participants	3 Participants	4 Participants	7 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 16: shift from cat 2 to cat 2	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 16: shift from cat 2 to cat 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 16: shift from cat 3 to cat 1	1 Participants	5 Participants	1 Participants	2 Participants	1 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 16: shift from cat 3 to cat 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline in the Electronic Columbia Suicide Severity Rating Scale (eC-SSRS) at Weeks 4, 12 and 16 Week 16: shift from cat 3 to cat 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes Baseline	4.568 10^12*cells/L Standard Deviation 0.392	4.537 10^12*cells/L Standard Deviation 0.375	4.510 10^12*cells/L Standard Deviation 0.365	4.516 10^12*cells/L Standard Deviation 0.429	4.563 10^12*cells/L Standard Deviation 0.406
Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes Week 2: Change from baseline	-0.106 10^12*cells/L Standard Deviation 0.262	-0.108 10^12*cells/L Standard Deviation 0.218	0.007 10^12*cells/L Standard Deviation 0.254	-0.095 10^12*cells/L Standard Deviation 0.215	-0.090 10^12*cells/L Standard Deviation 0.210
Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes Week 4: Change from baseline	-0.094 10^12*cells/L Standard Deviation 0.278	-0.083 10^12*cells/L Standard Deviation 0.217	0.072 10^12*cells/L Standard Deviation 0.200	-0.087 10^12*cells/L Standard Deviation 0.203	-0.077 10^12*cells/L Standard Deviation 0.229
Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes Week 12: Change from baseline	-0.057 10^12*cells/L Standard Deviation 0.277	-0.085 10^12*cells/L Standard Deviation 0.256	0.039 10^12*cells/L Standard Deviation 0.273	-0.057 10^12*cells/L Standard Deviation 0.265	-0.057 10^12*cells/L Standard Deviation 0.202
Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Erythrocytes Week 16: Change from baseline	-0.060 10^12*cells/L Standard Deviation 0.293	-0.023 10^12*cells/L Standard Deviation 0.250	-0.033 10^12*cells/L Standard Deviation 0.290	-0.085 10^12*cells/L Standard Deviation 0.254	-0.040 10^12*cells/L Standard Deviation 0.240

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit Baseline	0.4230 Volume proportion Standard Deviation 0.0347	0.4184 Volume proportion Standard Deviation 0.0303	0.4102 Volume proportion Standard Deviation 0.0384	0.4088 Volume proportion Standard Deviation 0.0312	0.4182 Volume proportion Standard Deviation 0.0346
Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit Week 2: Change from baseline	-0.0121 Volume proportion Standard Deviation 0.0261	-0.0079 Volume proportion Standard Deviation 0.0220	0.0016 Volume proportion Standard Deviation 0.0211	-0.0079 Volume proportion Standard Deviation 0.0195	-0.0138 Volume proportion Standard Deviation 0.0199
Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit Week 4: Change from baseline	-0.0097 Volume proportion Standard Deviation 0.0249	-0.0060 Volume proportion Standard Deviation 0.0194	0.0075 Volume proportion Standard Deviation 0.0144	-0.0080 Volume proportion Standard Deviation 0.0186	-0.0100 Volume proportion Standard Deviation 0.0234
Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit Week 12: Change from baseline	-0.0106 Volume proportion Standard Deviation 0.0294	-0.0036 Volume proportion Standard Deviation 0.0220	0.0087 Volume proportion Standard Deviation 0.0276	-0.0083 Volume proportion Standard Deviation 0.0258	-0.0115 Volume proportion Standard Deviation 0.0231
Change From Baseline at Weeks 2, 4, 12 and 16 for Clinical Laboratory Parameters Hematology: Hematocrit Week 16: Change from baseline	-0.0140 Volume proportion Standard Deviation 0.0258	-0.0006 Volume proportion Standard Deviation 0.0250	0.0015 Volume proportion Standard Deviation 0.0244	-0.0100 Volume proportion Standard Deviation 0.0235	-0.0099 Volume proportion Standard Deviation 0.0274

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin Baseline	138.4 g/L Standard Deviation 10.9	137.3 g/L Standard Deviation 10.0	136.4 g/L Standard Deviation 11.6	134.6 g/L Standard Deviation 9.8	135.6 g/L Standard Deviation 11.4
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin Week 2: Change from baseline	-3.0 g/L Standard Deviation 7.8	-3.0 g/L Standard Deviation 6.6	-0.2 g/L Standard Deviation 7.5	-2.8 g/L Standard Deviation 6.3	-2.5 g/L Standard Deviation 5.4
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin Week 4: Change from baseline	-2.7 g/L Standard Deviation 8.1	-2.6 g/L Standard Deviation 6.7	2.6 g/L Standard Deviation 5.3	-2.8 g/L Standard Deviation 5.7	-2.4 g/L Standard Deviation 6.2
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin Week 12: Change from baseline	-2.1 g/L Standard Deviation 7.7	-2.5 g/L Standard Deviation 7.5	0.8 g/L Standard Deviation 7.5	-2.3 g/L Standard Deviation 7.1	-1.5 g/L Standard Deviation 5.9
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Hemoglobin Week 16: Change from baseline	-1.9 g/L Standard Deviation 8.5	-0.7 g/L Standard Deviation 6.9	-1.7 g/L Standard Deviation 8.2	-2.6 g/L Standard Deviation 6.9	-1.1 g/L Standard Deviation 6.4

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume Baseline	92.74 fL Standard Deviation 4.65	92.39 fL Standard Deviation 4.51	90.92 fL Standard Deviation 3.00	90.82 fL Standard Deviation 5.25	91.88 fL Standard Deviation 5.69
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume Week 2: Change from baseline	-0.56 fL Standard Deviation 2.35	0.51 fL Standard Deviation 2.58	0.24 fL Standard Deviation 2.02	0.10 fL Standard Deviation 1.72	-1.29 fL Standard Deviation 3.35
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume Week 4: Change from baseline	-0.22 fL Standard Deviation 2.53	0.49 fL Standard Deviation 2.31	0.27 fL Standard Deviation 2.85	-0.10 fL Standard Deviation 1.92	-0.73 fL Standard Deviation 4.48
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume Week 12: Change from baseline	-1.22 fL Standard Deviation 3.30	0.98 fL Standard Deviation 3.41	1.18 fL Standard Deviation 2.72	-0.77 fL Standard Deviation 2.66	-1.47 fL Standard Deviation 4.49
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Erythrocytes Mean Corpuscular Volume Week 16: Change from baseline	-1.91 fL Standard Deviation 2.99	0.36 fL Standard Deviation 3.41	1.05 fL Standard Deviation 2.39	-0.55 fL Standard Deviation 4.13	-1.42 fL Standard Deviation 5.06

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 4: Change from baseline (Neutrophils)	0.11 10^9*cells/L Standard Deviation 1.04	0.09 10^9*cells/L Standard Deviation 0.86	0.14 10^9*cells/L Standard Deviation 0.70	-0.13 10^9*cells/L Standard Deviation 1.24	-0.16 10^9*cells/L Standard Deviation 0.91
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Baseline (Leukocytes)	6.09 10^9*cells/L Standard Deviation 1.80	6.17 10^9*cells/L Standard Deviation 1.89	6.32 10^9*cells/L Standard Deviation 1.35	6.31 10^9*cells/L Standard Deviation 1.74	6.40 10^9*cells/L Standard Deviation 1.76
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 2: Change from baseline (Leukocytes)	-0.19 10^9*cells/L Standard Deviation 1.02	-0.24 10^9*cells/L Standard Deviation 0.99	-0.13 10^9*cells/L Standard Deviation 0.97	-0.25 10^9*cells/L Standard Deviation 1.33	-0.12 10^9*cells/L Standard Deviation 1.44
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 4: Change from baseline (Leukocytes)	0.41 10^9*cells/L Standard Deviation 2.80	-0.09 10^9*cells/L Standard Deviation 0.96	0.16 10^9*cells/L Standard Deviation 1.02	-0.27 10^9*cells/L Standard Deviation 1.44	-0.20 10^9*cells/L Standard Deviation 1.04
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 12: Change from baseline (Leukocytes)	-0.12 10^9*cells/L Standard Deviation 1.28	-0.11 10^9*cells/L Standard Deviation 1.07	0.08 10^9*cells/L Standard Deviation 1.98	-0.29 10^9*cells/L Standard Deviation 1.55	-0.08 10^9*cells/L Standard Deviation 1.59
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 16: Change from baseline (Leukocytes)	-0.20 10^9*cells/L Standard Deviation 1.15	0.19 10^9*cells/L Standard Deviation 1.84	-0.05 10^9*cells/L Standard Deviation 1.20	-0.12 10^9*cells/L Standard Deviation 1.88	0.09 10^9*cells/L Standard Deviation 1.18
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Baseline (Platelets)	273.6 10^9*cells/L Standard Deviation 53.7	270.8 10^9*cells/L Standard Deviation 66.2	254.9 10^9*cells/L Standard Deviation 37.2	280.6 10^9*cells/L Standard Deviation 62.8	277.0 10^9*cells/L Standard Deviation 59.3
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 2: Change from baseline (Platelets)	0.6 10^9*cells/L Standard Deviation 36.2	-3.9 10^9*cells/L Standard Deviation 31.8	-6.0 10^9*cells/L Standard Deviation 22.4	-5.5 10^9*cells/L Standard Deviation 32.4	-3.0 10^9*cells/L Standard Deviation 30.7
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 4: Change from baseline (Platelets)	9.5 10^9*cells/L Standard Deviation 43.7	-2.1 10^9*cells/L Standard Deviation 27.6	7.6 10^9*cells/L Standard Deviation 35.8	-5.7 10^9*cells/L Standard Deviation 29.9	-1.4 10^9*cells/L Standard Deviation 34.4
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 12: Change from baseline (Platelets)	8.2 10^9*cells/L Standard Deviation 54.7	-0.5 10^9*cells/L Standard Deviation 33.1	14.7 10^9*cells/L Standard Deviation 23.9	0.0 10^9*cells/L Standard Deviation 30.6	1.3 10^9*cells/L Standard Deviation 45.7
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week16: Change from baseline (Platelets)	12.4 10^9*cells/L Standard Deviation 28.6	5.7 10^9*cells/L Standard Deviation 37.3	3.9 10^9*cells/L Standard Deviation 28.7	1.2 10^9*cells/L Standard Deviation 32.9	9.5 10^9*cells/L Standard Deviation 38.0
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Baseline (Basophils)	0.03 10^9*cells/L Standard Deviation 0.04	0.05 10^9*cells/L Standard Deviation 0.05	0.04 10^9*cells/L Standard Deviation 0.05	0.03 10^9*cells/L Standard Deviation 0.05	0.03 10^9*cells/L Standard Deviation 0.04
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 2: Change from baseline (Basophils)	0.00 10^9*cells/L Standard Deviation 0.04	0.00 10^9*cells/L Standard Deviation 0.02	-0.02 10^9*cells/L Standard Deviation 0.04	0.00 10^9*cells/L Standard Deviation 0.04	0.01 10^9*cells/L Standard Deviation 0.04
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 4: Change from baseline (Basophils)	0.00 10^9*cells/L Standard Deviation 0.05	-0.01 10^9*cells/L Standard Deviation 0.03	-0.02 10^9*cells/L Standard Deviation 0.04	-0.01 10^9*cells/L Standard Deviation 0.04	0.01 10^9*cells/L Standard Deviation 0.05
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 12: Change from baseline (Basophils)	0.00 10^9*cells/L Standard Deviation 0.04	-0.01 10^9*cells/L Standard Deviation 0.04	-0.02 10^9*cells/L Standard Deviation 0.06	0.00 10^9*cells/L Standard Deviation 0.05	0.00 10^9*cells/L Standard Deviation 0.03
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 16: Change from baseline (Basophils)	0.00 10^9*cells/L Standard Deviation 0.04	0.00 10^9*cells/L Standard Deviation 0.00	0.00 10^9*cells/L Standard Deviation 0.05	-0.01 10^9*cells/L Standard Deviation 0.04	0.01 10^9*cells/L Standard Deviation 0.05
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Baseline (Eosinophils)	0.14 10^9*cells/L Standard Deviation 0.09	0.19 10^9*cells/L Standard Deviation 0.12	0.18 10^9*cells/L Standard Deviation 0.15	0.20 10^9*cells/L Standard Deviation 0.24	0.18 10^9*cells/L Standard Deviation 0.14
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 2: Change from baseline (Eosinophils)	0.00 10^9*cells/L Standard Deviation 0.06	0.00 10^9*cells/L Standard Deviation 0.09	-0.01 10^9*cells/L Standard Deviation 0.07	-0.03 10^9*cells/L Standard Deviation 0.12	-0.02 10^9*cells/L Standard Deviation 0.09
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 4: Change from baseline (Eosinophils)	-0.01 10^9*cells/L Standard Deviation 0.09	-0.01 10^9*cells/L Standard Deviation 0.08	-0.01 10^9*cells/L Standard Deviation 0.11	-0.03 10^9*cells/L Standard Deviation 0.16	-0.02 10^9*cells/L Standard Deviation 0.07
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 12: Change from baseline (Eosinophils)	0.02 10^9*cells/L Standard Deviation 0.09	0.02 10^9*cells/L Standard Deviation 0.09	0.00 10^9*cells/L Standard Deviation 0.11	-0.05 10^9*cells/L Standard Deviation 0.19	-0.03 10^9*cells/L Standard Deviation 0.09
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 16: Change from baseline (Eosinophils)	0.00 10^9*cells/L Standard Deviation 0.10	-0.02 10^9*cells/L Standard Deviation 0.08	-0.01 10^9*cells/L Standard Deviation 0.13	-0.05 10^9*cells/L Standard Deviation 0.17	-0.02 10^9*cells/L Standard Deviation 0.11
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Baseline (Lymphocytes)	1.98 10^9*cells/L Standard Deviation 0.67	1.90 10^9*cells/L Standard Deviation 0.63	1.78 10^9*cells/L Standard Deviation 0.50	2.11 10^9*cells/L Standard Deviation 0.66	2.00 10^9*cells/L Standard Deviation 0.62
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 2: Change from baseline (Lymphocytes)	-0.06 10^9*cells/L Standard Deviation 0.34	-0.11 10^9*cells/L Standard Deviation 0.33	-0.10 10^9*cells/L Standard Deviation 0.31	-0.11 10^9*cells/L Standard Deviation 0.41	-0.14 10^9*cells/L Standard Deviation 0.39
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 4: Change from baseline (Lymphocytes)	-0.08 10^9*cells/L Standard Deviation 0.38	-0.13 10^9*cells/L Standard Deviation 0.34	0.04 10^9*cells/L Standard Deviation 0.45	-0.08 10^9*cells/L Standard Deviation 0.50	-0.02 10^9*cells/L Standard Deviation 0.38
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 12: Change from baseline (Lymphocytes)	-0.05 10^9*cells/L Standard Deviation 0.36	-0.08 10^9*cells/L Standard Deviation 0.34	-0.07 10^9*cells/L Standard Deviation 0.24	-0.09 10^9*cells/L Standard Deviation 0.47	-0.05 10^9*cells/L Standard Deviation 0.29
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 16: Change from baseline (Lymphocytes)	-0.14 10^9*cells/L Standard Deviation 0.46	-0.11 10^9*cells/L Standard Deviation 0.40	-0.07 10^9*cells/L Standard Deviation 0.32	-0.13 10^9*cells/L Standard Deviation 0.39	0.01 10^9*cells/L Standard Deviation 0.36
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Baseline (Monocytes)	0.44 10^9*cells/L Standard Deviation 0.13	0.47 10^9*cells/L Standard Deviation 0.14	0.51 10^9*cells/L Standard Deviation 0.10	0.47 10^9*cells/L Standard Deviation 0.14	0.46 10^9*cells/L Standard Deviation 0.17
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 2: Change from baseline (Monocytes)	0.00 10^9*cells/L Standard Deviation 0.09	-0.02 10^9*cells/L Standard Deviation 0.13	-0.02 10^9*cells/L Standard Deviation 0.13	-0.05 10^9*cells/L Standard Deviation 0.14	-0.01 10^9*cells/L Standard Deviation 0.11
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 4: Change from baseline (Monocytes)	0.02 10^9*cells/L Standard Deviation 0.09	-0.03 10^9*cells/L Standard Deviation 0.10	0.01 10^9*cells/L Standard Deviation 0.12	-0.03 10^9*cells/L Standard Deviation 0.11	-0.02 10^9*cells/L Standard Deviation 0.12
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 12: Change from baseline (Monocytes)	0.01 10^9*cells/L Standard Deviation 0.11	-0.03 10^9*cells/L Standard Deviation 0.10	-0.06 10^9*cells/L Standard Deviation 0.11	-0.03 10^9*cells/L Standard Deviation 0.13	0.00 10^9*cells/L Standard Deviation 0.15
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 16: Change from baseline (Monocytes)	0.01 10^9*cells/L Standard Deviation 0.11	-0.02 10^9*cells/L Standard Deviation 0.14	-0.03 10^9*cells/L Standard Deviation 0.13	0.00 10^9*cells/L Standard Deviation 0.13	0.00 10^9*cells/L Standard Deviation 0.14
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Baseline (Neutrophils)	3.50 10^9*cells/L Standard Deviation 1.34	3.59 10^9*cells/L Standard Deviation 1.33	3.81 10^9*cells/L Standard Deviation 1.13	3.51 10^9*cells/L Standard Deviation 1.41	3.73 10^9*cells/L Standard Deviation 1.28
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 2: Change from baseline (Neutrophils)	-0.14 10^9*cells/L Standard Deviation 0.79	-0.15 10^9*cells/L Standard Deviation 0.84	0.03 10^9*cells/L Standard Deviation 0.80	-0.08 10^9*cells/L Standard Deviation 1.24	0.01 10^9*cells/L Standard Deviation 1.32
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 12: Change from baseline (Neutrophils)	-0.11 10^9*cells/L Standard Deviation 1.16	-0.02 10^9*cells/L Standard Deviation 0.97	0.22 10^9*cells/L Standard Deviation 1.79	-0.13 10^9*cells/L Standard Deviation 1.26	-0.01 10^9*cells/L Standard Deviation 1.39
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Platelets, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 16: Change from baseline (Neutrophils)	-0.08 10^9*cells/L Standard Deviation 1.19	0.33 10^9*cells/L Standard Deviation 1.70	0.05 10^9*cells/L Standard Deviation 0.96	0.04 10^9*cells/L Standard Deviation 1.73	0.10 10^9*cells/L Standard Deviation 0.95

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Blood samples for clinical hematology assessment were collected and sent to the central laboratory for analysis.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Baseline (Basophils/ Leukocytes)	0.61 Percentage of total white blood cells Standard Deviation 0.36	0.72 Percentage of total white blood cells Standard Deviation 0.34	0.59 Percentage of total white blood cells Standard Deviation 0.26	0.69 Percentage of total white blood cells Standard Deviation 0.47	0.59 Percentage of total white blood cells Standard Deviation 0.31
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 2: Change from baseline (Basophils/ Leukocytes)	0.02 Percentage of total white blood cells Standard Deviation 0.22	-0.01 Percentage of total white blood cells Standard Deviation 0.19	-0.01 Percentage of total white blood cells Standard Deviation 0.18	-0.04 Percentage of total white blood cells Standard Deviation 0.30	0.07 Percentage of total white blood cells Standard Deviation 0.20
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 4: Change from baseline (Basophils/ Leukocytes)	0.03 Percentage of total white blood cells Standard Deviation 0.28	-0.04 Percentage of total white blood cells Standard Deviation 0.21	-0.02 Percentage of total white blood cells Standard Deviation 0.22	-0.06 Percentage of total white blood cells Standard Deviation 0.31	0.08 Percentage of total white blood cells Standard Deviation 0.30
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 12: Change from baseline (Basophils/ Leukocytes)	0.02 Percentage of total white blood cells Standard Deviation 0.35	0.01 Percentage of total white blood cells Standard Deviation 0.26	0.03 Percentage of total white blood cells Standard Deviation 0.15	-0.07 Percentage of total white blood cells Standard Deviation 0.31	0.05 Percentage of total white blood cells Standard Deviation 0.21
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 16: Change from baseline (Basophils/ Leukocytes)	0.00 Percentage of total white blood cells Standard Deviation 0.27	0.05 Percentage of total white blood cells Standard Deviation 0.20	0.06 Percentage of total white blood cells Standard Deviation 0.22	-0.05 Percentage of total white blood cells Standard Deviation 0.32	0.01 Percentage of total white blood cells Standard Deviation 0.19
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Baseline (Eosinophils/ Leukocytes)	2.17 Percentage of total white blood cells Standard Deviation 1.22	2.89 Percentage of total white blood cells Standard Deviation 1.67	2.66 Percentage of total white blood cells Standard Deviation 1.80	2.97 Percentage of total white blood cells Standard Deviation 3.43	2.76 Percentage of total white blood cells Standard Deviation 1.78
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 2: Change from baseline (Eosinophils/ Leukocytes)	0.16 Percentage of total white blood cells Standard Deviation 0.87	0.20 Percentage of total white blood cells Standard Deviation 1.01	-0.12 Percentage of total white blood cells Standard Deviation 0.75	-0.24 Percentage of total white blood cells Standard Deviation 1.78	-0.13 Percentage of total white blood cells Standard Deviation 1.17
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 4: Change from baseline (Eosinophils/ Leukocytes)	-0.13 Percentage of total white blood cells Standard Deviation 0.84	-0.06 Percentage of total white blood cells Standard Deviation 0.99	-0.15 Percentage of total white blood cells Standard Deviation 1.14	-0.43 Percentage of total white blood cells Standard Deviation 2.43	-0.17 Percentage of total white blood cells Standard Deviation 0.99
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 12: Change from baseline (Eosinophils/ Leukocytes)	0.33 Percentage of total white blood cells Standard Deviation 1.22	0.41 Percentage of total white blood cells Standard Deviation 1.49	0.11 Percentage of total white blood cells Standard Deviation 1.16	-0.53 Percentage of total white blood cells Standard Deviation 2.58	-0.27 Percentage of total white blood cells Standard Deviation 1.43
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week16: Change from baseline (Eosinophils/ Leukocytes)	0.10 Percentage of total white blood cells Standard Deviation 1.59	-0.15 Percentage of total white blood cells Standard Deviation 1.18	0.00 Percentage of total white blood cells Standard Deviation 1.53	-0.42 Percentage of total white blood cells Standard Deviation 2.33	-0.32 Percentage of total white blood cells Standard Deviation 1.57
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Baseline (Lymphocytes/ Leukocytes)	32.87 Percentage of total white blood cells Standard Deviation 7.02	31.31 Percentage of total white blood cells Standard Deviation 6.31	28.71 Percentage of total white blood cells Standard Deviation 7.07	34.20 Percentage of total white blood cells Standard Deviation 9.42	31.95 Percentage of total white blood cells Standard Deviation 7.49
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 2: Change from baseline (Lymphocytes/ Leukocytes)	0.27 Percentage of total white blood cells Standard Deviation 5.12	-0.54 Percentage of total white blood cells Standard Deviation 5.60	-1.32 Percentage of total white blood cells Standard Deviation 4.45	-0.83 Percentage of total white blood cells Standard Deviation 7.48	-1.37 Percentage of total white blood cells Standard Deviation 6.02
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 4: Change from baseline (Lymphocytes/ Leukocytes)	-1.24 Percentage of total white blood cells Standard Deviation 5.98	-1.25 Percentage of total white blood cells Standard Deviation 5.12	-0.89 Percentage of total white blood cells Standard Deviation 3.68	-0.43 Percentage of total white blood cells Standard Deviation 7.03	0.68 Percentage of total white blood cells Standard Deviation 4.85
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 12: Change from baseline (Lymphocytes/ Leukocytes)	-0.32 Percentage of total white blood cells Standard Deviation 6.82	-0.51 Percentage of total white blood cells Standard Deviation 6.59	0.13 Percentage of total white blood cells Standard Deviation 4.78	-0.41 Percentage of total white blood cells Standard Deviation 6.56	-0.07 Percentage of total white blood cells Standard Deviation 4.94
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 16: Change from baseline (Lymphocytes/ Leukocytes)	-0.89 Percentage of total white blood cells Standard Deviation 7.90	-1.40 Percentage of total white blood cells Standard Deviation 8.07	-0.75 Percentage of total white blood cells Standard Deviation 4.70	-0.95 Percentage of total white blood cells Standard Deviation 7.10	-0.70 Percentage of total white blood cells Standard Deviation 4.39
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Baseline (Monocytes/Leukocytes)	7.41 Percentage of total white blood cells Standard Deviation 1.76	7.71 Percentage of total white blood cells Standard Deviation 2.07	8.18 Percentage of total white blood cells Standard Deviation 1.62	7.55 Percentage of total white blood cells Standard Deviation 1.67	7.15 Percentage of total white blood cells Standard Deviation 1.67
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 2: Change from baseline (Monocytes/Leukocytes)	0.19 Percentage of total white blood cells Standard Deviation 1.11	0.05 Percentage of total white blood cells Standard Deviation 1.83	-0.24 Percentage of total white blood cells Standard Deviation 2.01	-0.36 Percentage of total white blood cells Standard Deviation 1.59	0.08 Percentage of total white blood cells Standard Deviation 1.20
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 4: Change from baseline (Monocytes/Leukocytes)	0.24 Percentage of total white blood cells Standard Deviation 1.31	-0.19 Percentage of total white blood cells Standard Deviation 1.24	-0.29 Percentage of total white blood cells Standard Deviation 1.71	-0.13 Percentage of total white blood cells Standard Deviation 1.25	0.21 Percentage of total white blood cells Standard Deviation 1.81
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 12: Change from baseline (Monocytes/Leukocytes)	0.45 Percentage of total white blood cells Standard Deviation 1.34	-0.19 Percentage of total white blood cells Standard Deviation 1.64	-0.67 Percentage of total white blood cells Standard Deviation 1.27	-0.01 Percentage of total white blood cells Standard Deviation 1.57	0.24 Percentage of total white blood cells Standard Deviation 1.52
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 16: Change from baseline (Monocytes/Leukocytes)	0.48 Percentage of total white blood cells Standard Deviation 1.67	-0.50 Percentage of total white blood cells Standard Deviation 1.75	-0.48 Percentage of total white blood cells Standard Deviation 1.45	0.27 Percentage of total white blood cells Standard Deviation 1.67	0.08 Percentage of total white blood cells Standard Deviation 1.68
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Baseline (Neutrophils/Leukocytes)	56.93 Percentage of total white blood cells Standard Deviation 8.12	57.37 Percentage of total white blood cells Standard Deviation 7.13	59.85 Percentage of total white blood cells Standard Deviation 8.07	54.59 Percentage of total white blood cells Standard Deviation 0.43	57.56 Percentage of total white blood cells Standard Deviation 8.01
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 2: Change from baseline (Neutrophils/Leukocytes)	-0.64 Percentage of total white blood cells Standard Deviation 6.11	0.29 Percentage of total white blood cells Standard Deviation 6.64	1.70 Percentage of total white blood cells Standard Deviation 5.11	1.47 Percentage of total white blood cells Standard Deviation 8.32	1.36 Percentage of total white blood cells Standard Deviation 6.75
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 4: Change from baseline (Neutrophils/Leukocytes)	1.10 Percentage of total white blood cells Standard Deviation 6.92	1.54 Percentage of total white blood cells Standard Deviation 5.78	1.35 Percentage of total white blood cells Standard Deviation 4.76	1.05 Percentage of total white blood cells Standard Deviation 8.38	-0.80 Percentage of total white blood cells Standard Deviation 6.01
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 12: Change from baseline (Neutrophils/Leukocytes)	-0.48 Percentage of total white blood cells Standard Deviation 7.92	0.27 Percentage of total white blood cells Standard Deviation 7.61	0.40 Percentage of total white blood cells Standard Deviation 5.40	1.01 Percentage of total white blood cells Standard Deviation 7.54	0.05 Percentage of total white blood cells Standard Deviation 5.60
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Hematology: Leukocytes, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils Week 16: Change from baseline (Neutrophils/Leukocytes)	0.30 Percentage of total white blood cells Standard Deviation 9.57	2.00 Percentage of total white blood cells Standard Deviation 9.27	1.17 Percentage of total white blood cells Standard Deviation 5.31	1.14 Percentage of total white blood cells Standard Deviation 8.14	0.94 Percentage of total white blood cells Standard Deviation 5.30

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Blood samples for clinical chemistry assessment were collected and sent to the central laboratory for analysis.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Baseline (Sodium)	141.3 mmol/L Standard Deviation 2.0	141.6 mmol/L Standard Deviation 2.4	141.6 mmol/L Standard Deviation 2.9	141.2 mmol/L Standard Deviation 1.8	141.3 mmol/L Standard Deviation 2.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 2: Change from baseline (Sodium)	-0.1 mmol/L Standard Deviation 1.9	0.1 mmol/L Standard Deviation 2.1	-0.6 mmol/L Standard Deviation 2.0	-0.5 mmol/L Standard Deviation 1.8	-0.5 mmol/L Standard Deviation 1.7
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 4: Change from baseline (Sodium)	-0.5 mmol/L Standard Deviation 1.7	-0.2 mmol/L Standard Deviation 2.1	-0.9 mmol/L Standard Deviation 2.4	-0.3 mmol/L Standard Deviation 1.8	0.0 mmol/L Standard Deviation 1.6
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 8: Change from baseline (Sodium)	0.0 mmol/L Standard Deviation 1.8	-0.8 mmol/L Standard Deviation 2.5	-0.6 mmol/L Standard Deviation 1.6	0.1 mmol/L Standard Deviation 2.0	0.1 mmol/L Standard Deviation 1.7
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 12: Change from baseline (Sodium)	-0.5 mmol/L Standard Deviation 1.9	-0.6 mmol/L Standard Deviation 2.5	-0.9 mmol/L Standard Deviation 1.7	0.0 mmol/L Standard Deviation 2.2	-0.1 mmol/L Standard Deviation 1.8
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 16: Change from baseline (Sodium)	-0.2 mmol/L Standard Deviation 1.7	-0.1 mmol/L Standard Deviation 2.1	-0.1 mmol/L Standard Deviation 2.0	-0.2 mmol/L Standard Deviation 2.0	-0.3 mmol/L Standard Deviation 1.8
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Baseline (Potassium)	4.51 mmol/L Standard Deviation 0.38	4.43 mmol/L Standard Deviation 0.30	4.23 mmol/L Standard Deviation 0.33	4.37 mmol/L Standard Deviation 0.44	4.36 mmol/L Standard Deviation 0.45
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 2: Change from baseline (Potassium)	-0.02 mmol/L Standard Deviation 0.35	-0.08 mmol/L Standard Deviation 0.36	0.06 mmol/L Standard Deviation 0.35	0.01 mmol/L Standard Deviation 0.44	-0.07 mmol/L Standard Deviation 0.40
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 4: Change from baseline (Potassium)	-0.04 mmol/L Standard Deviation 0.39	-0.09 mmol/L Standard Deviation 0.40	0.06 mmol/L Standard Deviation 0.27	-0.02 mmol/L Standard Deviation 0.45	-0.13 mmol/L Standard Deviation 0.31
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 8: Change from baseline (Potassium)	0.06 mmol/L Standard Deviation 0.39	-0.10 mmol/L Standard Deviation 0.34	-0.05 mmol/L Standard Deviation 0.30	0.02 mmol/L Standard Deviation 0.51	-0.11 mmol/L Standard Deviation 0.42
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 12: Change from baseline (Potassium)	-0.10 mmol/L Standard Deviation 0.40	-0.07 mmol/L Standard Deviation 0.34	0.10 mmol/L Standard Deviation 0.41	0.03 mmol/L Standard Deviation 0.51	-0.16 mmol/L Standard Deviation 0.40
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 16: Change from baseline (Potassium)	-0.13 mmol/L Standard Deviation 0.39	-0.10 mmol/L Standard Deviation 0.33	-0.04 mmol/L Standard Deviation 0.33	0.04 mmol/L Standard Deviation 0.45	-0.16 mmol/L Standard Deviation 0.40
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Baseline (Glucose)	5.06 mmol/L Standard Deviation 0.83	5.32 mmol/L Standard Deviation 1.11	5.16 mmol/L Standard Deviation 0.71	5.04 mmol/L Standard Deviation 0.74	5.81 mmol/L Standard Deviation 2.70
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 2: Change from baseline (Glucose)	0.22 mmol/L Standard Deviation 1.12	-0.07 mmol/L Standard Deviation 0.92	0.04 mmol/L Standard Deviation 1.01	0.28 mmol/L Standard Deviation 0.97	0.21 mmol/L Standard Deviation 1.89
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 4: Change from baseline (Glucose)	0.24 mmol/L Standard Deviation 0.73	0.02 mmol/L Standard Deviation 0.87	-0.24 mmol/L Standard Deviation 1.08	0.02 mmol/L Standard Deviation 0.87	-0.29 mmol/L Standard Deviation 2.39
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 8: Change from baseline (Glucose)	0.12 mmol/L Standard Deviation 0.54	-0.15 mmol/L Standard Deviation 1.15	-0.13 mmol/L Standard Deviation 1.17	0.01 mmol/L Standard Deviation 1.09	-0.12 mmol/L Standard Deviation 1.35
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 12: Change from baseline (Glucose)	-0.06 mmol/L Standard Deviation 0.94	-0.09 mmol/L Standard Deviation 1.06	0.13 mmol/L Standard Deviation 0.55	0.21 mmol/L Standard Deviation 1.48	-0.34 mmol/L Standard Deviation 1.82
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 16: Change from baseline (Glucose)	0.14 mmol/L Standard Deviation 0.81	0.06 mmol/L Standard Deviation 1.03	0.10 mmol/L Standard Deviation 0.94	0.09 mmol/L Standard Deviation 1.02	-0.43 mmol/L Standard Deviation 1.58
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Baseline (Urea Nitrogen)	5.74 mmol/L Standard Deviation 1.49	5.64 mmol/L Standard Deviation 1.54	5.70 mmol/L Standard Deviation 1.45	5.34 mmol/L Standard Deviation 1.51	5.31 mmol/L Standard Deviation 1.26
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 2: Change from baseline (Urea Nitrogen)	-0.43 mmol/L Standard Deviation 1.05	0.04 mmol/L Standard Deviation 1.21	0.50 mmol/L Standard Deviation 1.35	0.50 mmol/L Standard Deviation 1.25	0.24 mmol/L Standard Deviation 1.15
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 4: Change from baseline (Urea Nitrogen)	-0.30 mmol/L Standard Deviation 1.58	0.12 mmol/L Standard Deviation 0.95	0.17 mmol/L Standard Deviation 1.25	0.36 mmol/L Standard Deviation 1.42	0.12 mmol/L Standard Deviation 1.22
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 8: Change from baseline (Urea Nitrogen)	-0.23 mmol/L Standard Deviation 1.10	-0.34 mmol/L Standard Deviation 1.18	0.13 mmol/L Standard Deviation 1.71	0.53 mmol/L Standard Deviation 1.58	-0.03 mmol/L Standard Deviation 1.34
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 12: Change from baseline (Urea Nitrogen)	-0.21 mmol/L Standard Deviation 1.20	-0.17 mmol/L Standard Deviation 1.13	0.45 mmol/L Standard Deviation 2.11	0.31 mmol/L Standard Deviation 1.09	-0.10 mmol/L Standard Deviation 1.31
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 16: Change from baseline (Urea Nitrogen)	-0.24 mmol/L Standard Deviation 1.41	-0.19 mmol/L Standard Deviation 1.32	-0.03 mmol/L Standard Deviation 1.57	0.24 mmol/L Standard Deviation 1.11	-0.01 mmol/L Standard Deviation 1.25
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Baseline (Calcium)	2.348 mmol/L Standard Deviation 0.082	2.354 mmol/L Standard Deviation 0.093	2.325 mmol/L Standard Deviation 0.091	2.347 mmol/L Standard Deviation 0.117	2.342 mmol/L Standard Deviation 0.091
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 2: Change from baseline (Calcium)	-0.046 mmol/L Standard Deviation 0.081	-0.052 mmol/L Standard Deviation 0.082	0.011 mmol/L Standard Deviation 0.102	-0.019 mmol/L Standard Deviation 0.079	-0.050 mmol/L Standard Deviation 0.101
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 4: Change from baseline (Calcium)	-0.035 mmol/L Standard Deviation 0.094	-0.035 mmol/L Standard Deviation 0.077	0.028 mmol/L Standard Deviation 0.068	-0.018 mmol/L Standard Deviation 0.099	-0.036 mmol/L Standard Deviation 0.094
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 8: Change from baseline (Calcium)	-0.008 mmol/L Standard Deviation 0.109	-0.034 mmol/L Standard Deviation 0.085	0.002 mmol/L Standard Deviation 0.091	-0.021 mmol/L Standard Deviation 0.108	-0.042 mmol/L Standard Deviation 0.077
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 12: Change from baseline (Calcium)	-0.006 mmol/L Standard Deviation 0.088	-0.018 mmol/L Standard Deviation 0.091	0.014 mmol/L Standard Deviation 0.108	-0.014 mmol/L Standard Deviation 0.097	-0.042 mmol/L Standard Deviation 0.084
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 16 Change from baseline (Calcium)	-0.005 mmol/L Standard Deviation 0.090	-0.033 mmol/L Standard Deviation 0.093	0.003 mmol/L Standard Deviation 0.097	-0.009 mmol/L Standard Deviation 0.100	-0.027 mmol/L Standard Deviation 0.104
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Baseline (Phosphate)	1.28 mmol/L Standard Deviation 0.15	1.28 mmol/L Standard Deviation 0.15	1.17 mmol/L Standard Deviation 0.15	1.26 mmol/L Standard Deviation 0.16	1.22 mmol/L Standard Deviation 0.15
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 2: Change from baseline (Phosphate)	-0.02 mmol/L Standard Deviation 0.13	0.00 mmol/L Standard Deviation 0.13	0.03 mmol/L Standard Deviation 0.15	0.00 mmol/L Standard Deviation 0.15	-0.02 mmol/L Standard Deviation 0.17
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 4: Change from baseline (Phosphate)	0.00 mmol/L Standard Deviation 0.14	0.00 mmol/L Standard Deviation 0.16	0.05 mmol/L Standard Deviation 0.09	-0.01 mmol/L Standard Deviation 0.15	-0.03 mmol/L Standard Deviation 0.15
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 8: Change from baseline (Phosphate)	-0.01 mmol/L Standard Deviation 0.13	-0.02 mmol/L Standard Deviation 0.15	0.07 mmol/L Standard Deviation 0.11	0.02 mmol/L Standard Deviation 0.18	-0.02 mmol/L Standard Deviation 0.14
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 12: Change from baseline (Phosphate)	-0.02 mmol/L Standard Deviation 0.16	-0.02 mmol/L Standard Deviation 0.17	0.06 mmol/L Standard Deviation 0.15	0.02 mmol/L Standard Deviation 0.19	-0.06 mmol/L Standard Deviation 0.14
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 16: Change from baseline (Phosphate)	-0.02 mmol/L Standard Deviation 0.17	-0.01 mmol/L Standard Deviation 0.16	0.00 mmol/L Standard Deviation 0.14	-0.01 mmol/L Standard Deviation 0.17	-0.01 mmol/L Standard Deviation 0.13
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Baseline (Bicarbonate)	25.5 mmol/L Standard Deviation 2.4	26.6 mmol/L Standard Deviation 3.4	26.2 mmol/L Standard Deviation 3.7	26.7 mmol/L Standard Deviation 2.7	26.0 mmol/L Standard Deviation 2.9
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 2: Change from baseline (Bicarbonate)	0.3 mmol/L Standard Deviation 1.7	0.0 mmol/L Standard Deviation 2.0	-0.6 mmol/L Standard Deviation 2.3	-0.5 mmol/L Standard Deviation 2.1	-0.2 mmol/L Standard Deviation 2.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 4: Change from baseline (Bicarbonate)	0.2 mmol/L Standard Deviation 2.0	-0.1 mmol/L Standard Deviation 2.0	-0.1 mmol/L Standard Deviation 2.3	-0.4 mmol/L Standard Deviation 2.1	0.0 mmol/L Standard Deviation 1.7
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 8: Change from baseline (Bicarbonate)	0.3 mmol/L Standard Deviation 1.8	0.0 mmol/L Standard Deviation 2.3	-0.2 mmol/L Standard Deviation 2.1	-0.6 mmol/L Standard Deviation 1.9	0.3 mmol/L Standard Deviation 1.9
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 12: Change from baseline (Bicarbonate)	0.6 mmol/L Standard Deviation 2.1	-0.4 mmol/L Standard Deviation 2.1	-0.5 mmol/L Standard Deviation 2.4	-0.6 mmol/L Standard Deviation 1.9	-0.2 mmol/L Standard Deviation 1.9
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 16: Change from baseline (Bicarbonate)	0.4 mmol/L Standard Deviation 1.5	-0.1 mmol/L Standard Deviation 2.3	-0.5 mmol/L Standard Deviation 2.7	-0.3 mmol/L Standard Deviation 2.3	-0.1 mmol/L Standard Deviation 2.1
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Baseline (Magnesium)	0.809 mmol/L Standard Deviation 0.075	0.833 mmol/L Standard Deviation 0.084	0.826 mmol/L Standard Deviation 0.075	0.821 mmol/L Standard Deviation 0.067	0.817 mmol/L Standard Deviation 0.076
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 2: Change from baseline (Magnesium)	-0.011 mmol/L Standard Deviation 0.066	-0.027 mmol/L Standard Deviation 0.070	-0.009 mmol/L Standard Deviation 0.065	-0.013 mmol/L Standard Deviation 0.066	-0.037 mmol/L Standard Deviation 0.057
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 4: Change from baseline (Magnesium)	-0.008 mmol/L Standard Deviation 0.054	-0.035 mmol/L Standard Deviation 0.057	0.002 mmol/L Standard Deviation 0.052	-0.017 mmol/L Standard Deviation 0.061	-0.017 mmol/L Standard Deviation 0.060
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 8: Change from baseline (Magnesium)	0.005 mmol/L Standard Deviation 0.056	-0.016 mmol/L Standard Deviation 0.065	0.010 mmol/L Standard Deviation 0.048	0.005 mmol/L Standard Deviation 0.077	-0.008 mmol/L Standard Deviation 0.063
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 12: Change from baseline (Magnesium)	-0.033 mmol/L Standard Deviation 0.059	-0.025 mmol/L Standard Deviation 0.060	-0.035 mmol/L Standard Deviation 0.058	-0.012 mmol/L Standard Deviation 0.070	-0.016 mmol/L Standard Deviation 0.059
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 16: Change from baseline (Magnesium)	-0.024 mmol/L Standard Deviation 0.052	-0.043 mmol/L Standard Deviation 0.069	-0.022 mmol/L Standard Deviation 0.063	-0.025 mmol/L Standard Deviation 0.057	-0.022 mmol/L Standard Deviation 0.052
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Baseline (Chloride)	105.6 mmol/L Standard Deviation 2.2	105.4 mmol/L Standard Deviation 2.1	105.5 mmol/L Standard Deviation 2.4	104.8 mmol/L Standard Deviation 2.4	105.3 mmol/L Standard Deviation 2.6
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 2: Change from baseline (Chloride)	0.2 mmol/L Standard Deviation 2.0	0.3 mmol/L Standard Deviation 2.2	0.3 mmol/L Standard Deviation 2.2	0.5 mmol/L Standard Deviation 2.2	-0.1 mmol/L Standard Deviation 1.9
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 4: Change from baseline (Chloride)	-0.3 mmol/L Standard Deviation 1.7	-0.2 mmol/L Standard Deviation 1.8	-0.7 mmol/L Standard Deviation 2.5	0.3 mmol/L Standard Deviation 2.2	0.2 mmol/L Standard Deviation 2.1
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 8: Change from baseline (Chloride)	0.2 mmol/L Standard Deviation 1.9	-0.3 mmol/L Standard Deviation 2.0	-0.4 mmol/L Standard Deviation 1.8	0.5 mmol/L Standard Deviation 2.3	0.3 mmol/L Standard Deviation 1.6
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 12: Change from baseline (Chloride)	-0.5 mmol/L Standard Deviation 2.2	-0.1 mmol/L Standard Deviation 2.2	-0.3 mmol/L Standard Deviation 1.9	0.5 mmol/L Standard Deviation 2.3	0.8 mmol/L Standard Deviation 2.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Sodium, Potassium, Glucose, Urea Nitrogen, Calcium, Phosphate, Bicarbonate, Magnesium and Chloride Week 16: Change from baseline (Chloride)	-0.5 mmol/L Standard Deviation 1.8	0.2 mmol/L Standard Deviation 2.2	0.6 mmol/L Standard Deviation 2.6	0.1 mmol/L Standard Deviation 1.9	0.1 mmol/L Standard Deviation 2.2

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Blood samples for clinical chemistry assessment were collected and sent to the central laboratory for analysis.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin Baseline (Creatinine)	68.8 umol/L Standard Deviation 11.2	68.5 umol/L Standard Deviation 11.7	68.1 umol/L Standard Deviation 14.9	71.4 umol/L Standard Deviation 11.3	70.1 umol/L Standard Deviation 11.9
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin Week 2: Change from baseline (Creatinine)	0.8 umol/L Standard Deviation 7.2	-0.2 umol/L Standard Deviation 8.9	2.9 umol/L Standard Deviation 9.7	0.7 umol/L Standard Deviation 6.5	0.6 umol/L Standard Deviation 7.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin Week 4: Change from baseline (Creatinine)	-0.9 umol/L Standard Deviation 6.0	0.6 umol/L Standard Deviation 8.1	2.7 umol/L Standard Deviation 9.8	1.9 umol/L Standard Deviation 7.8	0.2 umol/L Standard Deviation 7.8
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin Week 8: Change from baseline (Creatinine)	1.0 umol/L Standard Deviation 6.3	-1.0 umol/L Standard Deviation 7.8	4.8 umol/L Standard Deviation 5.3	0.6 umol/L Standard Deviation 7.8	0.5 umol/L Standard Deviation 9.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin Week 12: Change from baseline (Creatinine)	0.7 umol/L Standard Deviation 8.9	2.1 umol/L Standard Deviation 7.7	4.2 umol/L Standard Deviation 11.2	-0.5 umol/L Standard Deviation 7.4	-2.8 umol/L Standard Deviation 8.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin Week 16: Change from baseline (Creatinine)	0.1 umol/L Standard Deviation 7.6	1.5 umol/L Standard Deviation 6.9	6.5 umol/L Standard Deviation 8.5	-0.9 umol/L Standard Deviation 8.2	-0.2 umol/L Standard Deviation 12.9
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin Baseline (Bilirubin)	9.1 umol/L Standard Deviation 4.1	8.4 umol/L Standard Deviation 2.9	8.9 umol/L Standard Deviation 3.1	9.6 umol/L Standard Deviation 5.0	8.1 umol/L Standard Deviation 2.8
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin Week 2: Change from baseline (Bilirubin)	-0.5 umol/L Standard Deviation 2.2	0.1 umol/L Standard Deviation 2.2	1.4 umol/L Standard Deviation 2.0	1.1 umol/L Standard Deviation 3.3	1.7 umol/L Standard Deviation 2.5
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin Week 4: Change from baseline (Bilirubin)	-0.2 umol/L Standard Deviation 2.6	0.4 umol/L Standard Deviation 2.7	2.3 umol/L Standard Deviation 2.8	1.0 umol/L Standard Deviation 3.3	1.3 umol/L Standard Deviation 3.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin Week 8: Change from baseline (Bilirubin)	-0.1 umol/L Standard Deviation 2.8	0.1 umol/L Standard Deviation 2.1	1.8 umol/L Standard Deviation 2.1	0.3 umol/L Standard Deviation 3.1	0.9 umol/L Standard Deviation 2.6
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin Week 12: Change from baseline (Bilirubin)	-0.1 umol/L Standard Deviation 2.4	0.7 umol/L Standard Deviation 2.4	0.8 umol/L Standard Deviation 2.7	-0.2 umol/L Standard Deviation 3.8	1.0 umol/L Standard Deviation 2.7
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine and Bilirubin Week 16: Change from baseline (Bilirubin)	0.2 umol/L Standard Deviation 2.4	-0.3 umol/L Standard Deviation 3.4	0.8 umol/L Standard Deviation 2.8	-0.8 umol/L Standard Deviation 3.7	-0.4 umol/L Standard Deviation 2.5

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Blood samples for clinical chemistry assessment were collected and sent to the central laboratory for analysis.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 16: Change from baseline (Aspartate Aminotransferase)	0.7 U/L Standard Deviation 5.1	0.9 U/L Standard Deviation 7.5	-2.4 U/L Standard Deviation 3.6	-0.2 U/L Standard Deviation 8.5	-2.2 U/L Standard Deviation 5.3
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Baseline (Creatine Kinase)	102.5 U/L Standard Deviation 117.2	91.6 U/L Standard Deviation 55.6	104.2 U/L Standard Deviation 62.0	161.8 U/L Standard Deviation 291.4	139.8 U/L Standard Deviation 159.3
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 2: Change from baseline (Creatine Kinase)	28.2 U/L Standard Deviation 161.8	7.1 U/L Standard Deviation 45.5	8.7 U/L Standard Deviation 59.6	-39.2 U/L Standard Deviation 280.5	-44.3 U/L Standard Deviation 154.1
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 4: Change from baseline (Creatine Kinase)	-1.3 U/L Standard Deviation 36.8	2.7 U/L Standard Deviation 23.4	4.3 U/L Standard Deviation 44.2	-30.2 U/L Standard Deviation 293.1	-40.1 U/L Standard Deviation 163.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 8: Change from baseline (Creatine Kinase)	15.5 U/L Standard Deviation 106.6	30.6 U/L Standard Deviation 127.3	158.1 U/L Standard Deviation 580.1	-36.9 U/L Standard Deviation 275.8	4.0 U/L Standard Deviation 76.1
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Baseline (Alanine Aminotransferase)	27.0 U/L Standard Deviation 8.7	24.0 U/L Standard Deviation 7.6	23.9 U/L Standard Deviation 10.0	24.4 U/L Standard Deviation 10.0	25.9 U/L Standard Deviation 9.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 12: Change from baseline (Creatine Kinase)	7.2 U/L Standard Deviation 49.7	16.1 U/L Standard Deviation 44.7	11.7 U/L Standard Deviation 116.5	-13.3 U/L Standard Deviation 77.4	-40.3 U/L Standard Deviation 174.5
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 16: Change from baseline (Creatine Kinase)	7.3 U/L Standard Deviation 37.3	3.2 U/L Standard Deviation 34.3	5.6 U/L Standard Deviation 54.8	-48.8 U/L Standard Deviation 267.0	-44.1 U/L Standard Deviation 172.2
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Baseline (Alkaline Phosphatase)	79.8 U/L Standard Deviation 24.1	85.9 U/L Standard Deviation 18.4	80.6 U/L Standard Deviation 19.4	91.3 U/L Standard Deviation 43.4	86.1 U/L Standard Deviation 25.5
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 2: Change from baseline (Alkaline Phosphatase)	-1.5 U/L Standard Deviation 8.4	-1.9 U/L Standard Deviation 14.6	-2.2 U/L Standard Deviation 6.3	-2.5 U/L Standard Deviation 6.7	-3.0 U/L Standard Deviation 8.2
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 4: Change from baseline (Alkaline Phosphatase)	-1.1 U/L Standard Deviation 6.1	-5.2 U/L Standard Deviation 8.6	3.2 U/L Standard Deviation 13.1	-3.8 U/L Standard Deviation 8.1	-4.1 U/L Standard Deviation 8.8
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 8: Change from baseline (Alkaline Phosphatase)	-2.0 U/L Standard Deviation 8.5	-5.0 U/L Standard Deviation 10.8	-1.0 U/L Standard Deviation 6.2	-5.1 U/L Standard Deviation 10.8	-4.5 U/L Standard Deviation 12.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 12: Change from baseline (Alkaline Phosphatase)	-0.5 U/L Standard Deviation 8.2	-3.2 U/L Standard Deviation 8.9	0.2 U/L Standard Deviation 11.5	-4.4 U/L Standard Deviation 11.8	-4.5 U/L Standard Deviation 8.1
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 16: Change from baseline (Alkaline Phosphatase)	-0.1 U/L Standard Deviation 8.5	-0.6 U/L Standard Deviation 14.2	-4.9 U/L Standard Deviation 10.4	-0.1 U/L Standard Deviation 9.6	-2.6 U/L Standard Deviation 8.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Baseline (Aspartate Aminotransferase)	24.7 U/L Standard Deviation 6.0	24.4 U/L Standard Deviation 6.5	24.4 U/L Standard Deviation 5.1	24.8 U/L Standard Deviation 8.0	24.9 U/L Standard Deviation 6.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 2: Change from baseline (Aspartate Aminotransferase)	0.9 U/L Standard Deviation 7.1	0.0 U/L Standard Deviation 4.0	0.1 U/L Standard Deviation 4.2	-2.0 U/L Standard Deviation 7.6	-2.3 U/L Standard Deviation 6.1
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 4: Change from baseline (Aspartate Aminotransferase)	1.5 U/L Standard Deviation 6.3	-0.2 U/L Standard Deviation 3.8	4.6 U/L Standard Deviation 17.7	-1.8 U/L Standard Deviation 6.7	-0.3 U/L Standard Deviation 6.9
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 8: Change from baseline (Aspartate Aminotransferase)	-1.3 U/L Standard Deviation 5.0	-0.5 U/L Standard Deviation 4.7	3.4 U/L Standard Deviation 24.2	-1.8 U/L Standard Deviation 6.9	-1.2 U/L Standard Deviation 5.2
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 12: Change from baseline (Aspartate Aminotransferase)	-1.1 U/L Standard Deviation 4.3	0.3 U/L Standard Deviation 3.5	0.9 U/L Standard Deviation 8.1	-1.8 U/L Standard Deviation 4.7	-2.0 U/L Standard Deviation 7.6
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 2: Change from baseline (Alanine Aminotransferase)	0.8 U/L Standard Deviation 10.6	-0.1 U/L Standard Deviation 5.1	-0.7 U/L Standard Deviation 5.6	-2.1 U/L Standard Deviation 6.7	-3.0 U/L Standard Deviation 7.6
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 4: Change from baseline (Alanine Aminotransferase)	3.5 U/L Standard Deviation 11.6	-1.0 U/L Standard Deviation 5.5	16.4 U/L Standard Deviation 70.2	-2.1 U/L Standard Deviation 5.3	-1.1 U/L Standard Deviation 9.5
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 8: Change from baseline (Alanine Aminotransferase)	-0.7 U/L Standard Deviation 6.1	-0.3 U/L Standard Deviation 5.2	0.6 U/L Standard Deviation 12.2	-0.4 U/L Standard Deviation 9.2	-0.7 U/L Standard Deviation 10.6
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 12: Change from baseline (Alanine Aminotransferase)	-0.5 U/L Standard Deviation 7.4	0.7 U/L Standard Deviation 6.0	4.3 U/L Standard Deviation 21.0	-0.6 U/L Standard Deviation 6.8	-1.2 U/L Standard Deviation 9.1
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 16: Change from baseline (Alanine Aminotransferase)	2.5 U/L Standard Deviation 13.1	2.0 U/L Standard Deviation 9.1	-3.5 U/L Standard Deviation 6.9	3.1 U/L Standard Deviation 12.0	-2.4 U/L Standard Deviation 6.7
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Baseline (Gamma Glutamyl Transferase )	24.6 U/L Standard Deviation 17.4	25.1 U/L Standard Deviation 15.0	19.3 U/L Standard Deviation 15.3	25.5 U/L Standard Deviation 23.2	25.9 U/L Standard Deviation 28.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 2: Change from baseline (Gamma Glutamyl Transferase)	-0.2 U/L Standard Deviation 11.3	0.0 U/L Standard Deviation 7.1	-1.9 U/L Standard Deviation 6.7	-2.7 U/L Standard Deviation 8.4	-1.0 U/L Standard Deviation 7.6
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 4: Change from baseline (Gamma Glutamyl Transferase)	3.0 U/L Standard Deviation 14.8	-0.6 U/L Standard Deviation 9.1	3.6 U/L Standard Deviation 14.7	-3.5 U/L Standard Deviation 10.6	1.4 U/L Standard Deviation 14.6
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 8: Change from baseline (Gamma Glutamyl Transferase)	-1.5 U/L Standard Deviation 6.4	0.1 U/L Standard Deviation 9.2	0.6 U/L Standard Deviation 5.9	-2.8 U/L Standard Deviation 13.6	3.3 U/L Standard Deviation 22.6
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 12: Change from baseline (Gamma Glutamyl Transferase)	-1.2 U/L Standard Deviation 10.7	1.5 U/L Standard Deviation 9.8	4.8 U/L Standard Deviation 13.2	-3.0 U/L Standard Deviation 14.3	1.3 U/L Standard Deviation 16.2
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Creatinine Kinase, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase and Gamma Glutamyl Transferase Week 16: Change from baseline (Gamma Glutamyl Transferase)	-0.7 U/L Standard Deviation 8.8	2.2 U/L Standard Deviation 10.1	1.8 U/L Standard Deviation 14.4	-0.7 U/L Standard Deviation 10.1	-0.2 U/L Standard Deviation 16.4

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Blood samples for clinical chemistry assessment were collected and sent to the central laboratory for analysis.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin Baseline (Protein)	67.4 g/L Standard Deviation 4.0	67.5 g/L Standard Deviation 4.3	66.5 g/L Standard Deviation 5.1	67.7 g/L Standard Deviation 4.3	67.0 g/L Standard Deviation 4.7
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin Week 2: Change from baseline (Protein)	-1.7 g/L Standard Deviation 2.9	-2.1 g/L Standard Deviation 4.6	-0.4 g/L Standard Deviation 3.7	-1.5 g/L Standard Deviation 2.9	-2.1 g/L Standard Deviation 3.7
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin Week 4: Change from baseline (Protein)	-1.8 g/L Standard Deviation 3.0	-1.5 g/L Standard Deviation 4.1	0.2 g/L Standard Deviation 3.3	-1.6 g/L Standard Deviation 2.7	-1.5 g/L Standard Deviation 3.5
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin Week 8: Change from baseline (Protein)	-1.5 g/L Standard Deviation 3.4	-2.3 g/L Standard Deviation 4.2	-1.7 g/L Standard Deviation 4.2	-2.0 g/L Standard Deviation 3.8	-2.4 g/L Standard Deviation 3.3
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin Week 12: Change from baseline (Protein)	-1.5 g/L Standard Deviation 3.0	-1.5 g/L Standard Deviation 3.9	-0.7 g/L Standard Deviation 4.6	-1.7 g/L Standard Deviation 3.4	-1.8 g/L Standard Deviation 3.2
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin Week 16: Change from baseline (Protein)	-1.0 g/L Standard Deviation 3.2	-1.6 g/L Standard Deviation 4.1	-1.9 g/L Standard Deviation 5.0	-1.8 g/L Standard Deviation 3.7	-1.7 g/L Standard Deviation 4.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin Baseline (Albumin)	44.7 g/L Standard Deviation 2.1	44.9 g/L Standard Deviation 2.8	43.6 g/L Standard Deviation 2.4	45.2 g/L Standard Deviation 2.4	44.2 g/L Standard Deviation 3.0
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin Week 2: Change from baseline (Albumin)	-1.3 g/L Standard Deviation 1.9	-1.4 g/L Standard Deviation 2.6	-0.1 g/L Standard Deviation 2.4	-0.9 g/L Standard Deviation 1.8	-1.3 g/L Standard Deviation 2.4
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin Week 4: Change from baseline (Albumin)	-0.9 g/L Standard Deviation 2.1	-1.0 g/L Standard Deviation 2.3	0.5 g/L Standard Deviation 2.2	-0.8 g/L Standard Deviation 1.9	-0.7 g/L Standard Deviation 2.6
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin Week 8: Change from baseline (Albumin)	-0.8 g/L Standard Deviation 2.2	-1.2 g/L Standard Deviation 2.7	-0.9 g/L Standard Deviation 2.5	-0.8 g/L Standard Deviation 2.6	-1.3 g/L Standard Deviation 2.2
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin Week 12: Change from baseline (Albumin)	-0.6 g/L Standard Deviation 1.9	-0.7 g/L Standard Deviation 2.1	0.3 g/L Standard Deviation 2.6	-0.6 g/L Standard Deviation 2.5	-0.7 g/L Standard Deviation 2.2
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Protein and Albumin Week 16: Change from baseline (Albumin)	0.0 g/L Standard Deviation 2.0	-0.4 g/L Standard Deviation 2.0	0.1 g/L Standard Deviation 3.1	-0.6 g/L Standard Deviation 2.3	-0.4 g/L Standard Deviation 2.8

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 8, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Blood samples for clinical chemistry assessment were collected and sent to the central laboratory for analysis.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C Baseline	39.22 mmol/mol Standard Deviation 8.09	39.05 mmol/mol Standard Deviation 5.82	35.84 mmol/mol Standard Deviation 3.39	38.78 mmol/mol Standard Deviation 5.65	40.88 mmol/mol Standard Deviation 10.97
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C Week 2: Change from baseline	-0.42 mmol/mol Standard Deviation 1.46	0.04 mmol/mol Standard Deviation 1.18	0.19 mmol/mol Standard Deviation 1.46	-0.08 mmol/mol Standard Deviation 1.35	-0.21 mmol/mol Standard Deviation 2.32
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C Week 4: Change from baseline	-0.29 mmol/mol Standard Deviation 1.91	0.00 mmol/mol Standard Deviation 1.96	0.06 mmol/mol Standard Deviation 1.47	-0.02 mmol/mol Standard Deviation 1.55	-0.43 mmol/mol Standard Deviation 4.24
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C Week 8: Change from baseline	-0.40 mmol/mol Standard Deviation 2.38	0.26 mmol/mol Standard Deviation 2.16	0.62 mmol/mol Standard Deviation 2.13	-0.13 mmol/mol Standard Deviation 1.72	-0.28 mmol/mol Standard Deviation 5.11
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C Week 12: Change from baseline	0.07 mmol/mol Standard Deviation 1.96	0.84 mmol/mol Standard Deviation 3.01	1.57 mmol/mol Standard Deviation 2.46	0.55 mmol/mol Standard Deviation 2.30	-0.94 mmol/mol Standard Deviation 5.33
Change From Baseline at Weeks 2, 4, 8, 12 and 16 in Clinical Laboratory Parameters Biochemistry: Hemoglobin A1C Week 16: Change from baseline	-0.64 mmol/mol Standard Deviation 2.41	0.69 mmol/mol Standard Deviation 2.64	1.16 mmol/mol Standard Deviation 2.13	-0.04 mmol/mol Standard Deviation 2.22	-1.07 mmol/mol Standard Deviation 5.65

SECONDARY outcome

Timeframe: From baseline to Weeks 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Blood for assessment of bone turnover markers was collected and sent to the central laboratory for analysis.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide Baseline (Bone Specific Alkaline Phosphatase)	12.17 ug/L Standard Deviation 5.08	13.01 ug/L Standard Deviation 5.09	13.94 ug/L Standard Deviation 4.67	13.37 ug/L Standard Deviation 4.69	13.36 ug/L Standard Deviation 4.83
Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide Week 12: Change from baseline (Bone Specific Alkaline Phosphatase)	0.48 ug/L Standard Deviation 2.22	0.34 ug/L Standard Deviation 4.24	-0.68 ug/L Standard Deviation 3.36	-0.43 ug/L Standard Deviation 2.50	-0.11 ug/L Standard Deviation 2.73
Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide Week 16: Change from baseline (Bone Specific Alkaline Phosphatase)	0.86 ug/L Standard Deviation 3.57	1.22 ug/L Standard Deviation 7.58	-1.18 ug/L Standard Deviation 2.49	0.84 ug/L Standard Deviation 3.55	0.48 ug/L Standard Deviation 2.98
Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide Baseline (Procollagen 1 N-Terminal Propeptide)	58.1 ug/L Standard Deviation 23.3	68.0 ug/L Standard Deviation 24.7	67.6 ug/L Standard Deviation 15.6	68.6 ug/L Standard Deviation 29.3	59.5 ug/L Standard Deviation 23.6
Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide Week 12: Change from baseline (Procollagen 1 N-Terminal Propeptide)	5.0 ug/L Standard Deviation 14.5	0.5 ug/L Standard Deviation 10.9	-5.7 ug/L Standard Deviation 15.9	-2.1 ug/L Standard Deviation 13.7	-0.7 ug/L Standard Deviation 10.9
Change From Baseline at Weeks 12 and 16 in Clinical Laboratory Parameters Bone: Bone Specific Alkaline Phosphatase and Procollagen 1 N-Terminal Propeptide Week 16: Change from baseline (Procollagen 1 N-Terminal Propeptide)	3.6 ug/L Standard Deviation 20.2	-1.9 ug/L Standard Deviation 9.7	-0.9 ug/L Standard Deviation 19.6	-2.5 ug/L Standard Deviation 15.4	0.0 ug/L Standard Deviation 11.7

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Urine for urinalysis was collected and sent to the central laboratory for analysis. Urine pH was measured on a pH scale.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH Baseline (pH)	6.00 pH Standard Deviation 0.83	6.10 pH Standard Deviation 0.89	6.09 pH Standard Deviation 0.92	6.21 pH Standard Deviation 0.75	6.08 pH Standard Deviation 0.72
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH Week 2: Change from baseline (pH)	0.10 pH Standard Deviation 0.70	0.26 pH Standard Deviation 0.90	-0.15 pH Standard Deviation 0.95	-0.30 pH Standard Deviation 0.83	-0.20 pH Standard Deviation 0.83
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH Week 4: Change from baseline (pH)	-0.11 pH Standard Deviation 0.85	0.18 pH Standard Deviation 1.31	-0.09 pH Standard Deviation 0.80	-0.25 pH Standard Deviation 0.83	-0.09 pH Standard Deviation 0.89
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH Week 12: Change from baseline (pH)	-0.05 pH Standard Deviation 0.89	0.18 pH Standard Deviation 1.06	-0.19 pH Standard Deviation 0.83	-0.21 pH Standard Deviation 0.78	-0.06 pH Standard Deviation 0.79
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: pH Week 16: Change from baseline (pH)	0.05 pH Standard Deviation 1.13	0.00 pH Standard Deviation 1.12	-0.03 pH Standard Deviation 0.90	-0.19 pH Standard Deviation 0.84	0.07 pH Standard Deviation 1.04

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Urine for urinalysis was collected and sent to the central laboratory for analysis.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity Baseline (Specific Gravity)	1.0167 Unitless Standard Deviation 0.0063	1.0167 Unitless Standard Deviation 0.0083	1.0166 Unitless Standard Deviation 0.0063	1.0154 Unitless Standard Deviation 0.0064	1.0171 Unitless Standard Deviation 0.0084
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity Week 2: Change from baseline (Specific Gravity)	-0.0002 Unitless Standard Deviation 0.0066	-0.0011 Unitless Standard Deviation 0.0085	0.0001 Unitless Standard Deviation 0.0060	0.0005 Unitless Standard Deviation 0.0068	-0.0006 Unitless Standard Deviation 0.0060
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity Week 4: Change from baseline (Specific Gravity)	-0.0008 Unitless Standard Deviation 0.0078	0.0012 Unitless Standard Deviation 0.0086	-0.0026 Unitless Standard Deviation 0.0063	0.0015 Unitless Standard Deviation 0.0067	0.0003 Unitless Standard Deviation 0.0079
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity Week 12: Change from baseline (Specific Gravity)	0.0020 Unitless Standard Deviation 0.0068	0.0015 Unitless Standard Deviation 0.0102	-0.0012 Unitless Standard Deviation 0.0060	0.0002 Unitless Standard Deviation 0.0068	0.0011 Unitless Standard Deviation 0.0072
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Specific Gravity Week 16: Change from baseline (Specific Gravity)	0.0009 Unitless Standard Deviation 0.0088	0.0002 Unitless Standard Deviation 0.0093	-0.0011 Unitless Standard Deviation 0.0059	0.0020 Unitless Standard Deviation 0.0066	-0.0006 Unitless Standard Deviation 0.0066

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data.

Urine for urinalysis was collected and sent to the central laboratory for analysis. Clinical relevance was judged by the investigator. Assessment was done using standard laboratory practice.

For evaluation of the chemical properties of the urine sample test strips were used which have test pads of chemicals that change color when they come in contact with reagents. The degree of color change correlates with the amount of reagent present. Each color block represents a range of values. Range and direction of scores for reagents nitrite and urobilinogen: negative = normal; positive = abnormal. Range and direction of scores for all other reagents tested: negative = normal; trace, 1+, 2+, 3+ = abnormal, the higher the value, the higher the concentration of the reagent tested.

Outcome measures

Measure	Placebo n=47 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Ketones): Negative	44 Participants	31 Participants	17 Participants	51 Participants	50 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Glucose): 1+	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Glucose): 2+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Ketones): Trace	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Ketones): Negative	45 Participants	31 Participants	17 Participants	50 Participants	48 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Bilirubin): 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Glucose): 3+	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Glucose): Negative	45 Participants	30 Participants	17 Participants	51 Participants	46 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Bilirubin): Negative	45 Participants	31 Participants	17 Participants	51 Participants	48 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Glucose): Trace	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Glucose): 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Glucose): 2+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Glucose): 3+	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Glucose): Negative	43 Participants	30 Participants	16 Participants	47 Participants	40 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Glucose): Trace	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Glucose): 1+	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Glucose): 2+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Glucose): 3+	0 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Glucose): Negative	40 Participants	29 Participants	16 Participants	50 Participants	43 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Glucose): Trace	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Glucose): 1+	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Glucose): 2+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Glucose): 3+	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Bilirubin): Negative	47 Participants	31 Participants	17 Participants	49 Participants	51 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Bilirubin): 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Bilirubin): Negative	44 Participants	31 Participants	17 Participants	52 Participants	51 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Bilirubin): 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Bilirubin): Negative	41 Participants	29 Participants	16 Participants	51 Participants	44 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Bilirubin): Negative	43 Participants	30 Participants	16 Participants	49 Participants	44 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Bilirubin): 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Bilirubin): 1+	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Glucose): 3+	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Glucose): Negative	44 Participants	31 Participants	17 Participants	52 Participants	49 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Glucose): Trace	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Glucose): Negative	46 Participants	30 Participants	17 Participants	49 Participants	48 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Glucose): Trace	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Glucose): 1+	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Glucose): 2+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Ketones): Negative	46 Participants	31 Participants	17 Participants	48 Participants	50 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Ketones): Trace	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Ketones): Trace	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Ketones): Negative	42 Participants	30 Participants	16 Participants	48 Participants	43 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Ketones): Trace	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Ketones): Negative	41 Participants	30 Participants	16 Participants	50 Participants	44 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Ketones): Trace	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Occult Blood): Negative	46 Participants	28 Participants	15 Participants	42 Participants	47 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Occult Blood): Trace	0 Participants	3 Participants	1 Participants	3 Participants	4 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Occult Blood): 1+	1 Participants	0 Participants	0 Participants	3 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Occult Blood): 2+	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Occult Blood): 3+	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Occult Blood): Negative	42 Participants	29 Participants	17 Participants	45 Participants	47 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Occult Blood): Trace	1 Participants	2 Participants	0 Participants	1 Participants	3 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Occult Blood): 1+	1 Participants	0 Participants	0 Participants	5 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Occult Blood): 2+	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Occult Blood): 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Occult Blood): Negative	43 Participants	28 Participants	17 Participants	42 Participants	47 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Occult Blood): Trace	2 Participants	1 Participants	0 Participants	5 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Occult Blood): 1+	0 Participants	2 Participants	0 Participants	3 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Occult Blood): 2+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Occult Blood): 3+	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Occult Blood): Negative	40 Participants	30 Participants	13 Participants	40 Participants	42 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Occult Blood): Trace	1 Participants	0 Participants	1 Participants	5 Participants	2 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Occult Blood): 1+	2 Participants	0 Participants	1 Participants	3 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Occult Blood): 2+	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Occult Blood): 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Occult Blood): Negative	38 Participants	27 Participants	14 Participants	45 Participants	39 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Occult Blood): Trace	2 Participants	3 Participants	1 Participants	3 Participants	4 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Occult Blood): 1+	0 Participants	0 Participants	0 Participants	3 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Occult Blood): 2+	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Occult Blood): 3+	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Protein): Negative	45 Participants	31 Participants	16 Participants	48 Participants	49 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Protein): Trace	2 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Protein): 1+	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Protein): 2+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Protein): 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Protein): Negative	44 Participants	31 Participants	17 Participants	52 Participants	49 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Protein): Trace	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Protein): 1+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Protein): 2+	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Protein): 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Protein): Negative	44 Participants	31 Participants	17 Participants	49 Participants	45 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Protein): Trace	0 Participants	0 Participants	0 Participants	2 Participants	3 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Protein): 1+	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Protein): 2+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Protein): 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Protein): Negative	41 Participants	30 Participants	14 Participants	47 Participants	43 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Protein): Trace	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Protein): 1+	1 Participants	0 Participants	2 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Protein): 2+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Protein): 3+	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Protein): Negative	39 Participants	30 Participants	15 Participants	50 Participants	43 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Protein): Trace	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Protein): 1+	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Protein): 2+	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Protein): 3+	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Urobilinogen): Negative	47 Participants	31 Participants	17 Participants	49 Participants	51 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Urobilinogen): Negative	44 Participants	31 Participants	17 Participants	52 Participants	51 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Urobilinogen): Negative	45 Participants	31 Participants	17 Participants	51 Participants	48 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Urobilinogen): Negative	43 Participants	30 Participants	16 Participants	49 Participants	44 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Urobilinogen): Negative	41 Participants	30 Participants	16 Participants	51 Participants	44 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Nitrite): Negative	47 Participants	29 Participants	17 Participants	48 Participants	48 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Baseline (Nitrite): Positive	0 Participants	2 Participants	0 Participants	1 Participants	3 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Nitrite): Negative	44 Participants	29 Participants	17 Participants	51 Participants	47 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 2 (Nitrite): Positive	0 Participants	2 Participants	0 Participants	1 Participants	4 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Nitrite): Negative	45 Participants	29 Participants	17 Participants	50 Participants	47 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 4 (Nitrite): Positive	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Nitrite): Negative	42 Participants	29 Participants	16 Participants	49 Participants	42 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 12 (Nitrite): Positive	1 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Nitrite): Negative	41 Participants	30 Participants	16 Participants	51 Participants	42 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Glucose, Bilirubin, Ketones, Occult Blood, Protein, Urobilinogen and Nitrite Week 16 (Nitrite): Positive	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data at baseline and each week were reported. Only some participants have baseline or post baseline value for this endpoint therefore the numbers are much lower than expected.

Urine for urinalysis was collected and sent to the central laboratory for analysis. Results are reported according to the amount present in the microscope's field of view at high magnification (/HPF [high-power field]).

Outcome measures

Measure	Placebo n=18 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=12 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=7 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=23 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=23 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes Week 2: Change from baseline (Leukocytes (/HPF))	-6.7 cells/HPF Standard Deviation 15.9	0.0 cells/HPF Standard Deviation 3.6	0.5 cells/HPF Standard Deviation 2.1	-1.0 cells/HPF Standard Deviation 2.7	-0.4 cells/HPF Standard Deviation 6.4
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes Baseline (Erythrocytes (/HPF))	1.3 cells/HPF Standard Deviation 1.5	0.8 cells/HPF Standard Deviation 1.1	2.0 cells/HPF Standard Deviation 2.6	1.5 cells/HPF Standard Deviation 2.4	0.6 cells/HPF Standard Deviation 0.7
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes Week 2: Change from baseline (Erythrocytes (/HPF))	-0.6 cells/HPF Standard Deviation 2.6	-0.6 cells/HPF Standard Deviation 0.5	-1.0 cells/HPF Standard Deviation 1.4	-0.8 cells/HPF Standard Deviation 4.0	0.9 cells/HPF Standard Deviation 3.0
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes Week 4: Change from baseline (Erythrocytes (/HPF))	-0.1 cells/HPF Standard Deviation 1.6	0.5 cells/HPF Standard Deviation 1.3	-2.7 cells/HPF Standard Deviation 3.1	-0.5 cells/HPF Standard Deviation 3.1	0.3 cells/HPF Standard Deviation 1.1
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes Week 12: Change from baseline (Erythrocytes (/HPF))	-0.4 cells/HPF Standard Deviation 2.2	-0.4 cells/HPF Standard Deviation 0.8	0.4 cells/HPF Standard Deviation 0.5	1.4 cells/HPF Standard Deviation 3.7	0.2 cells/HPF Standard Deviation 1.5
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes Week 16: Change from baseline (Erythrocytes (/HPF))	-0.3 cells/HPF Standard Deviation 2.1	-0.7 cells/HPF Standard Deviation 1.2	-1.5 cells/HPF Standard Deviation 2.4	0.3 cells/HPF Standard Deviation 2.1	0.1 cells/HPF Standard Deviation 0.3
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes Baseline (Leukocytes (/HPF))	9.5 cells/HPF Standard Deviation 16.2	2.6 cells/HPF Standard Deviation 4.3	1.6 cells/HPF Standard Deviation 1.7	5.3 cells/HPF Standard Deviation 11.9	3.0 cells/HPF Standard Deviation 5.8
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes Week 4: Change from baseline (Leukocytes (/HPF))	-6.0 cells/HPF Standard Deviation 20.9	1.0 cells/HPF Standard Deviation 1.0	6.3 cells/HPF Standard Deviation 11.8	0.3 cells/HPF Standard Deviation 4.1	0.8 cells/HPF Standard Deviation 5.8
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes Week 12: Change from baseline (Leukocytes (/HPF))	6.4 cells/HPF Standard Deviation 47.9	3.5 cells/HPF Standard Deviation 6.7	0.6 cells/HPF Standard Deviation 3.0	0.6 cells/HPF Standard Deviation 2.3	-1.5 cells/HPF Standard Deviation 5.1
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Erythrocytes and Leukocytes Week 16: Change from baseline (Leukocytes (/HPF))	-7.6 cells/HPF Standard Deviation 21.9	3.0 cells/HPF Standard Deviation 4.4	3.0 cells/HPF Standard Deviation 4.2	0.6 cells/HPF Standard Deviation 1.3	13.3 cells/HPF Standard Deviation 33.4

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data at baseline and each week were reported. Only some participants have baseline or post baseline value for this endpoint therefore the numbers are much lower than expected.

Urine for urinalysis was collected and sent to the central laboratory for analysis. Results are reported according to the amount present in the microscope's field of view at low magnification (/LPF [low-power field]).

Outcome measures

Measure	Placebo n=18 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=12 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=7 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=23 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=23 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts Baseline (Hyaline Casts (/LPF)	1.9 cells/LPF Standard Deviation 2.0	0.8 cells/LPF Standard Deviation 1.6	0.1 cells/LPF Standard Deviation 0.4	0.8 cells/LPF Standard Deviation 1.4	1.7 cells/LPF Standard Deviation 6.2
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts Week 2: Change from baseline (Hyaline Casts (/LPF))	-1.1 cells/LPF Standard Deviation 2.7	-0.6 cells/LPF Standard Deviation 1.5	0.0 cells/LPF Standard Deviation 0.0	-0.1 cells/LPF Standard Deviation 0.6	0.1 cells/LPF Standard Deviation 1.5
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts Week 4: Change from baseline (Hyaline Casts (/LPF))	-0.2 cells/LPF Standard Deviation 3.6	-0.5 cells/LPF Standard Deviation 1.0	5.3 cells/LPF Standard Deviation 6.8	0.3 cells/LPF Standard Deviation 1.8	-0.4 cells/LPF Standard Deviation 1.7
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts Week 12: Change from baseline (Hyaline Casts (/LPF))	-0.3 cells/LPF Standard Deviation 2.8	-0.1 cells/LPF Standard Deviation 1.5	2.2 cells/LPF Standard Deviation 4.4	-0.3 cells/LPF Standard Deviation 0.8	-2.8 cells/LPF Standard Deviation 9.0
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Hyaline Casts Week 16: Change from baseline (Hyaline Casts (/LPF))	-1.2 cells/LPF Standard Deviation 2.9	0.7 cells/LPF Standard Deviation 1.2	0.5 cells/LPF Standard Deviation 1.0	0.1 cells/LPF Standard Deviation 0.8	-0.2 cells/LPF Standard Deviation 0.8

SECONDARY outcome

Timeframe: From baseline to Weeks 2, 4, 12 and 16

Population: Participants in safety analysis set (SAF) with evaluable data at baseline and each week were reported. Only some participants have baseline or post baseline value for this endpoint therefore the numbers are much lower than expected.

Urine for urinalysis was collected and sent to the central laboratory for analysis. The evaluation of components in the urine samples such as bacteria, yeast, red blood cells (RBC), white blood cells (WBC), casts and crystals was performed by microscopy. Results are reported according to the amount present in the microscope's field of view at low magnification (/LPF [low-power field]) and high magnification (/HPF [high-power field]).

Range and direction of scores microscopic identification of urine components:

• Bacteria: none seen, 1+, 2+, 3+,4+, TNTC (too numerous to count).
• Other urine components: none seen=normal; few, moderate, many, TNTC = abnormal. The higher the value, the higher the concentration of the component evaluated.

Outcome measures

Measure	Placebo n=13 Participants Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=11 Participants Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=8 Participants Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=18 Participants Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=19 Participants Participants received 4x40 mg elinzanetant capsules.
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Uric Acid Crystals(/HPF)): None seen	11 Participants	6 Participants	3 Participants	14 Participants	12 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Uric Acid Crystals(/HPF)): Few	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Uric Acid Crystals(/HPF)): Moderate	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Yeast Cells(/HPF)): None seen	13 Participants	6 Participants	5 Participants	12 Participants	14 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Uric Acid Crystals(/HPF)): None seen	11 Participants	8 Participants	8 Participants	18 Participants	12 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Uric Acid Crystals(/HPF)): Few	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Yeast Cells(/HPF)): Few	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Granular Casts(/LPF)): None seen	9 Participants	11 Participants	5 Participants	17 Participants	19 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2: (Granular Casts(/LPF)): None seen	8 Participants	9 Participants	3 Participants	11 Participants	18 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Uric Acid Crystals(/HPF)): Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4: (Granular Casts(/LPF)): None seen	11 Participants	6 Participants	3 Participants	15 Participants	13 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Uric Acid Crystals(/HPF)): None seen	13 Participants	6 Participants	4 Participants	11 Participants	14 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Uric Acid Crystals(/HPF)): Few	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Uric Acid Crystals(/HPF)): Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12: (Granular Casts(/LPF)): None seen	12 Participants	8 Participants	8 Participants	18 Participants	12 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16: (Granular Casts(/LPF)): None seen	13 Participants	6 Participants	5 Participants	12 Participants	14 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (RBC Casts(/LPF)): None seen	9 Participants	11 Participants	5 Participants	17 Participants	19 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (RBC Casts(/LPF)): None seen	8 Participants	9 Participants	3 Participants	11 Participants	18 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (RBC Casts(/LPF)): None seen	11 Participants	6 Participants	3 Participants	15 Participants	13 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (RBC Casts(/LPF)): None seen	12 Participants	8 Participants	8 Participants	18 Participants	12 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (RBC Casts(/LPF)): None seen	13 Participants	6 Participants	5 Participants	12 Participants	14 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Waxy Casts(/LPF)): None seen	9 Participants	11 Participants	5 Participants	17 Participants	19 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Waxy Casts(/LPF)): None seen	8 Participants	9 Participants	3 Participants	11 Participants	18 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Waxy Casts(/LPF)): None seen	11 Participants	6 Participants	3 Participants	15 Participants	13 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Bacteria(/HPF)): None seen	4 Participants	4 Participants	2 Participants	9 Participants	7 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Bacteria(/HPF)): 1+	4 Participants	3 Participants	1 Participants	6 Participants	5 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Bacteria(/HPF)): 2+	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Bacteria(/HPF)): 3+	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Bacteria(/HPF)): 4+	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Waxy Casts(/LPF)): None seen	12 Participants	8 Participants	8 Participants	18 Participants	12 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Bacteria(/HPF)): TNTC	1 Participants	2 Participants	0 Participants	0 Participants	2 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Bacteria(/HPF)): None seen	3 Participants	3 Participants	1 Participants	5 Participants	6 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Bacteria(/HPF)): 1+	1 Participants	2 Participants	1 Participants	4 Participants	4 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Waxy Casts(/LPF)): None seen	13 Participants	6 Participants	5 Participants	12 Participants	14 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Bacteria(/HPF)): 2+	1 Participants	2 Participants	1 Participants	0 Participants	6 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Bacteria(/HPF)): 3+	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Bacteria(/HPF)): 4+	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Bacteria(/HPF)): TNTC	1 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (WBC Casts(/LPF)): None seen	9 Participants	11 Participants	5 Participants	17 Participants	19 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Bacteria(/HPF)): None seen	7 Participants	3 Participants	1 Participants	9 Participants	2 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (WBC Casts(/LPF)): None seen	8 Participants	9 Participants	3 Participants	11 Participants	18 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (WBC Casts(/LPF)): None seen	11 Participants	6 Participants	3 Participants	15 Participants	13 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Bacteria(/HPF)): 1+	0 Participants	0 Participants	1 Participants	1 Participants	3 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Bacteria(/HPF)): 2+	2 Participants	0 Participants	1 Participants	4 Participants	3 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Bacteria(/HPF)): 3+	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Bacteria(/HPF)): 4+	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (WBC Casts(/LPF)): None seen	12 Participants	8 Participants	8 Participants	18 Participants	12 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Bacteria(/HPF)): TNTC	2 Participants	3 Participants	0 Participants	1 Participants	2 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Bacteria(/HPF)): None seen	1 Participants	3 Participants	3 Participants	11 Participants	3 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Bacteria(/HPF)): 1+	7 Participants	2 Participants	3 Participants	3 Participants	3 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (WBC Casts(/LPF)): None seen	13 Participants	6 Participants	5 Participants	12 Participants	14 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Bacteria(/HPF)): 2+	1 Participants	0 Participants	2 Participants	3 Participants	5 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Bacteria(/HPF)): 3+	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Bacteria(/HPF)): 4+	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Calcium Oxalate Crystals(/HPF)): None seen	8 Participants	11 Participants	5 Participants	13 Participants	16 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Bacteria(/HPF)): TNTC	2 Participants	2 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Bacteria(/HPF)): None seen	2 Participants	3 Participants	2 Participants	6 Participants	4 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Bacteria(/HPF)): 1+	5 Participants	0 Participants	0 Participants	3 Participants	3 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Calcium Oxalate Crystals(/HPF)): Few	1 Participants	0 Participants	0 Participants	2 Participants	2 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Bacteria(/HPF)): 2+	4 Participants	2 Participants	1 Participants	1 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Bacteria(/HPF)): 3+	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Bacteria(/HPF)): 4+	1 Participants	1 Participants	2 Participants	0 Participants	3 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Calcium Oxalate Crystals(/HPF)): Moderate	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Bacteria(/HPF)): TNTC	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Yeast Cells(/HPF)): None seen	9 Participants	11 Participants	5 Participants	17 Participants	19 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Yeast Cells(/HPF)): Few	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Yeast Cells(/HPF)): None seen	8 Participants	9 Participants	3 Participants	11 Participants	17 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Yeast Cells(/HPF)): Few	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Calcium Oxalate Crystals(/HPF)): Many	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Yeast Cells(/HPF)): None seen	11 Participants	6 Participants	3 Participants	15 Participants	13 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Calcium Oxalate Crystals(/HPF)): TNTC	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Calcium Oxalate Crystals(/HPF)): None seen	6 Participants	8 Participants	3 Participants	9 Participants	17 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Calcium Oxalate Crystals(/HPF)): Few	2 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Calcium Oxalate Crystals(/HPF)): Moderate	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Calcium Oxalate Crystals(/HPF)): Many	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Calcium Oxalate Crystals(/HPF)): TNTC	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Yeast Cells(/HPF)): Few	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Calcium Oxalate Crystals(/HPF)): None seen	9 Participants	5 Participants	3 Participants	12 Participants	10 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Calcium Oxalate Crystals(/HPF)): Few	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Calcium Oxalate Crystals(/HPF)): Moderate	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Yeast Cells(/HPF)): None seen	12 Participants	8 Participants	8 Participants	18 Participants	12 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Calcium Oxalate Crystals(/HPF)): Many	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Calcium Oxalate Crystals(/HPF)): TNTC	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Calcium Oxalate Crystals(/HPF)): None seen	11 Participants	7 Participants	8 Participants	16 Participants	11 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Calcium Oxalate Crystals(/HPF)): Few	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Calcium Oxalate Crystals(/HPF)): Moderate	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Calcium Oxalate Crystals(/HPF)): Many	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Calcium Oxalate Crystals(/HPF)): TNTC	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Calcium Oxalate Crystals(/HPF)): None seen	10 Participants	4 Participants	5 Participants	11 Participants	14 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Calcium Oxalate Crystals(/HPF)): Few	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Calcium Oxalate Crystals(/HPF)): Moderate	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Calcium Oxalate Crystals(/HPF)): Many	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Calcium Oxalate Crystals(/HPF)): TNTC	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Triple Phosphate Crystals(/HPF)): None seen	9 Participants	11 Participants	5 Participants	17 Participants	19 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Triple Phosphate Crystals(/HPF)): None seen	8 Participants	9 Participants	3 Participants	11 Participants	18 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Yeast Cells(/HPF)): Few	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 4 (Triple Phosphate Crystals(/HPF)): None seen	11 Participants	6 Participants	3 Participants	15 Participants	13 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 12 (Triple Phosphate Crystals(/HPF)): None seen	12 Participants	8 Participants	8 Participants	18 Participants	12 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 16 (Triple Phosphate Crystals(/HPF)): None seen	13 Participants	6 Participants	5 Participants	12 Participants	14 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Uric Acid Crystals(/HPF)): None seen	9 Participants	11 Participants	5 Participants	16 Participants	19 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Uric Acid Crystals(/HPF)): Few	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Baseline (Uric Acid Crystals(/HPF)): Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Uric Acid Crystals(/HPF)): None seen	8 Participants	9 Participants	3 Participants	11 Participants	18 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Uric Acid Crystals(/HPF)): Few	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Change From Baseline at Weeks 2, 4, 12 and 16 in Clinical Laboratory Parameters Urinalysis: Bacteria, Yeast Cells, Granular Casts, RBC Casts, Waxy Casts, WBC Casts, Calcium Oxalate Crystals, Triple Phosphate Crystals and Uric Acid Crystals Week 2 (Uric Acid Crystals(/HPF)): Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 18 other events

Deaths: 0 deaths

40 mg Elinzanetant (BAY3427080)

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

80 mg Elinzanetant (BAY3427080)

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

120 mg Elinzanetant (BAY3427080)

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

160 mg Elinzanetant (BAY3427080)

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=47 participants at risk Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 participants at risk Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 participants at risk Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 participants at risk Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 participants at risk Participants received 4x40 mg elinzanetant capsules.
Infections and infestations Sepsis	2.1% 1/47 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/17 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Infections and infestations Tooth abscess	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/17 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	1.9% 1/52 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	2.1% 1/47 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/17 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Nervous system disorders Migraine	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/17 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	1.9% 1/52 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Renal and urinary disorders Nephrolithiasis	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.

Other adverse events

Measure	Placebo n=47 participants at risk Participants received four placebo capsules orally once daily in the evening before bedtime.	40 mg Elinzanetant (BAY3427080) n=31 participants at risk Participants received one 40 mg elinzanetant capsule and 3 placebo capsules.	80 mg Elinzanetant (BAY3427080) n=17 participants at risk Participants received 2x40 mg elinzanetant capsules and 2 placebo capsules.	120 mg Elinzanetant (BAY3427080) n=52 participants at risk Participants received 3x40 mg elinzanetant capsules and 1 placebo capsule.	160 mg Elinzanetant (BAY3427080) n=52 participants at risk Participants received 4x40 mg elinzanetant capsules.
Cardiac disorders Bradycardia	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	1.9% 1/52 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Gastrointestinal disorders Diarrhoea	6.4% 3/47 • Number of events 3 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	6.5% 2/31 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	11.8% 2/17 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.8% 3/52 • Number of events 3 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.8% 3/52 • Number of events 3 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Gastrointestinal disorders Flatulence	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Gastrointestinal disorders Nausea	4.3% 2/47 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	6.5% 2/31 • Number of events 4 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	11.8% 2/17 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	1.9% 1/52 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	3.8% 2/52 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
General disorders Fatigue	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	9.7% 3/31 • Number of events 3 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	1.9% 1/52 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	7.7% 4/52 • Number of events 4 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
General disorders Non-cardiac chest pain	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Infections and infestations Herpes zoster	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	11.8% 2/17 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Infections and infestations Nasopharyngitis	8.5% 4/47 • Number of events 4 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	3.2% 1/31 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/17 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.8% 3/52 • Number of events 3 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Infections and infestations Urinary tract infection	2.1% 1/47 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	6.5% 2/31 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/17 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	3.8% 2/52 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	3.8% 2/52 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	3.8% 2/52 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Infections and infestations Viral sinusitis	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Injury, poisoning and procedural complications Arthropod bite	2.1% 1/47 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	6.5% 2/31 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/17 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	1.9% 1/52 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	1.9% 1/52 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Investigations Aspartate aminotransferase increased	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	1.9% 1/52 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Investigations Blood creatine phosphokinase increased	2.1% 1/47 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	3.2% 1/31 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.8% 3/52 • Number of events 3 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	1.9% 1/52 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Investigations Electrocardiogram QT prolonged	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Investigations Liver function test increased	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Musculoskeletal and connective tissue disorders Joint swelling	2.1% 1/47 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Nervous system disorders Dizziness	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/17 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.8% 3/52 • Number of events 4 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.8% 3/52 • Number of events 3 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Nervous system disorders Headache	12.8% 6/47 • Number of events 8 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	9.7% 3/31 • Number of events 3 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	11.8% 2/17 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	11.5% 6/52 • Number of events 7 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	7.7% 4/52 • Number of events 6 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Nervous system disorders Somnolence	2.1% 1/47 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	9.7% 3/31 • Number of events 3 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	3.8% 2/52 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	11.5% 6/52 • Number of events 6 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Psychiatric disorders Depressed mood	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	3.8% 2/52 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Psychiatric disorders Insomnia	2.1% 1/47 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	1.9% 1/52 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Renal and urinary disorders Haematuria	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Renal and urinary disorders Nephrolithiasis	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	1.9% 1/52 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Reproductive system and breast disorders Breast tenderness	2.1% 1/47 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	1.9% 1/52 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Respiratory, thoracic and mediastinal disorders Cough	4.3% 2/47 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	1.9% 1/52 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/47 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	6.5% 2/31 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/17 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/52 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	3.8% 2/52 • Number of events 2 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.
Skin and subcutaneous tissue disorders Rash	2.1% 1/47 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	0.00% 0/31 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	5.9% 1/17 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	1.9% 1/52 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.	1.9% 1/52 • Number of events 1 • On or after first dosing with randomised study treatment up to Week 16. Adverse event reporting for the all-cause mortality considers all deaths that occurred at any time during the study, up to 1 year.

Additional Information

Therapeutic Area Head

Bayer AG

Phone: 1-888-8422937

Email: clinical-trials-contact@bayer.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI is required to postpone communication of results until a joint, multicenter publication of the multicenter study has occurred, or the sponsor confirms that no joint publication will be prepared, or 18 months since completion of the data analysis have passed. The sponsor can review planned publications for up to 60 days and request reasonable amendments. The review period can be extended by up to 6 months in case a patent application is planned.
• Publication restrictions are in place

Restriction type: OTHER