Trial Outcomes & Findings for Efficacy and Safety of S-equol on Vasomotor Symptoms in Menopausal Patients (NCT NCT00962585)

NCT ID: NCT00962585

Last Updated: 2014-04-08

Results Overview

The primary efficacy endpoint for this study was the change from Baseline (Day 0) in the frequency of MSVS (difference between Baseline \[2-week run-in period\] and Week 4), where the baseline MSVS frequency was captured over 14 ± 2 day period. Moderate is defined as "sensation of heat with sweating, able to continue activity"; severe is defined as "sensation of heat with sweating, causing cessation of activity". Patients used the take-home daily diary to record MSVS information during the run-in period and treatment period and analyses were performed as specified. Treatment group differences are estimated using least squares (LS) means and 95% confidence intervals based on the mean square error from the ANCOVA. LSMeans refer to overall adjusted mean frequency of MSVS.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 169 participants
• Primary outcome timeframe: 4 weeks from Baseline (2-week run-in period)
• Results posted on: 2014-04-08

Participant Flow

Patients for this trial were screened from 9 investigative sites in the United States and Australia. Participants were women of menopausal status and experiencing vasomotor symptoms and nocturnal sweating.

After completing screening visit assessments, subjects were instructed to refrain from taking prohibited medications throughout the study. Patients who were taking prohibited medications at the time of the screening visit discontinued their use and completed a suitable washout period before progressing to the next visit.

Participant milestones

Measure	S-equol 10 mg BID 20 mg total daily dose of S-equol	S-equol 50 mg BID 100 mg total daily dose of S-equol	S-equol 150 mg BID 300 mg total daily dose of S-equol	Placebo Placebo treatment arm
Overall Study STARTED	43	42	42	42
Overall Study COMPLETED	37	40	39	42
Overall Study NOT COMPLETED	6	2	3	0

Reasons for withdrawal

Measure	S-equol 10 mg BID 20 mg total daily dose of S-equol	S-equol 50 mg BID 100 mg total daily dose of S-equol	S-equol 150 mg BID 300 mg total daily dose of S-equol	Placebo Placebo treatment arm
Overall Study Adverse Event	0	2	1	0
Overall Study Lost to Follow-up	3	0	1	0
Overall Study Protocol Violation	0	0	1	0
Overall Study Withdrawal by Subject	1	0	0	0
Overall Study Withdrew Consent	2	0	0	0

Baseline Characteristics

Efficacy and Safety of S-equol on Vasomotor Symptoms in Menopausal Patients

Baseline characteristics by cohort

Measure	S-equol 10 mg BID n=43 Participants 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 Participants 100 mg total daily dose of S-equol	S-equol 150 mg BID n=42 Participants 300 mg total daily dose of S-equol	Placebo n=42 Participants Placebo treatment arm	Total n=169 Participants Total of all reporting groups
Age, Customized	53.8 years STANDARD_DEVIATION 7.9 • n=5 Participants	53.1 years STANDARD_DEVIATION 6.9 • n=7 Participants	54.9 years STANDARD_DEVIATION 5.8 • n=5 Participants	56.2 years STANDARD_DEVIATION 6.7 • n=4 Participants	54.5 years STANDARD_DEVIATION 6.9 • n=21 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	42 Participants n=7 Participants	42 Participants n=5 Participants	42 Participants n=4 Participants	169 Participants n=21 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
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Black or African American	4 participants n=5 Participants	7 participants n=7 Participants	10 participants n=5 Participants	5 participants n=4 Participants	26 participants n=21 Participants
Race/Ethnicity, Customized White	39 participants n=5 Participants	35 participants n=7 Participants	32 participants n=5 Participants	34 participants n=4 Participants	140 participants n=21 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	2 participants n=21 Participants
Height	165.3 centimeters STANDARD_DEVIATION 5.1 • n=5 Participants	164.1 centimeters STANDARD_DEVIATION 4.6 • n=7 Participants	165.4 centimeters STANDARD_DEVIATION 6.7 • n=5 Participants	163.3 centimeters STANDARD_DEVIATION 5.9 • n=4 Participants	164.5 centimeters STANDARD_DEVIATION 5.6 • n=21 Participants
Weight	74.1 kilograms STANDARD_DEVIATION 11.6 • n=5 Participants	73.0 kilograms STANDARD_DEVIATION 10.7 • n=7 Participants	74.4 kilograms STANDARD_DEVIATION 10.1 • n=5 Participants	73.2 kilograms STANDARD_DEVIATION 12.8 • n=4 Participants	73.7 kilograms STANDARD_DEVIATION 11.3 • n=21 Participants
Body Mass Index	27.1 kilogram/meter^2 STANDARD_DEVIATION 3.9 • n=5 Participants	27.1 kilogram/meter^2 STANDARD_DEVIATION 4.1 • n=7 Participants	27.2 kilogram/meter^2 STANDARD_DEVIATION 3.5 • n=5 Participants	27.4 kilogram/meter^2 STANDARD_DEVIATION 4.1 • n=4 Participants	27.2 kilogram/meter^2 STANDARD_DEVIATION 3.9 • n=21 Participants

PRIMARY outcome

Timeframe: 4 weeks from Baseline (2-week run-in period)

Population: The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.

The primary efficacy endpoint for this study was the change from Baseline (Day 0) in the frequency of MSVS (difference between Baseline [2-week run-in period] and Week 4), where the baseline MSVS frequency was captured over 14 ± 2 day period. Moderate is defined as "sensation of heat with sweating, able to continue activity"; severe is defined as "sensation of heat with sweating, causing cessation of activity". Patients used the take-home daily diary to record MSVS information during the run-in period and treatment period and analyses were performed as specified.

Treatment group differences are estimated using least squares (LS) means and 95% confidence intervals based on the mean square error from the ANCOVA. LSMeans refer to overall adjusted mean frequency of MSVS.

Outcome measures

Measure	S-equol 10 mg BID n=42 Participants 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 Participants 100 mg total daily dose of S-equol	S-equol 150 mg BID n=41 Participants 300 mg total daily dose of S-equol	Placebo n=42 Participants Placebo treatment arm
Mean Change in Frequency of Moderate to Severe Vasomotor Symptoms (MSVS) Baseline at Week 4 (2-week Period) Baseline (Day 0)	73.5 Number of MSVS/2 weeks Interval 65.3 to 81.8	69.5 Number of MSVS/2 weeks Interval 64.0 to 75.1	70.4 Number of MSVS/2 weeks Interval 63.5 to 77.3	67.9 Number of MSVS/2 weeks Interval 61.4 to 74.4
Mean Change in Frequency of Moderate to Severe Vasomotor Symptoms (MSVS) Baseline at Week 4 (2-week Period) Week 4	41.7 Number of MSVS/2 weeks 95% Confidence Interval 32.8 • Interval 31.0 to 52.5	46.1 Number of MSVS/2 weeks 95% Confidence Interval 27.8 • Interval 37.5 to 54.8	39.3 Number of MSVS/2 weeks 95% Confidence Interval 27.3 • Interval 30.5 to 48.0	39.3 Number of MSVS/2 weeks 95% Confidence Interval 25.1 • Interval 31.5 to 47.1
Mean Change in Frequency of Moderate to Severe Vasomotor Symptoms (MSVS) Baseline at Week 4 (2-week Period) LSMean	40.78 Number of MSVS/2 weeks Interval 32.72 to 48.84	46.63 Number of MSVS/2 weeks Interval 38.87 to 54.39	40.59 Number of MSVS/2 weeks Interval 32.58 to 48.59	39.65 Number of MSVS/2 weeks Interval 31.89 to 47.41
Mean Change in Frequency of Moderate to Severe Vasomotor Symptoms (MSVS) Baseline at Week 4 (2-week Period) Change from Baseline at Week 4	-30.1 Number of MSVS/2 weeks 95% Confidence Interval 29.0 • Interval -39.7 to -20.6	-23.4 Number of MSVS/2 weeks 95% Confidence Interval 30.2 • Interval -32.8 to -14.0	-31.1 Number of MSVS/2 weeks 95% Confidence Interval 23.4 • Interval -38.6 to -23.7	-28.6 Number of MSVS/2 weeks 95% Confidence Interval 22.1 • Interval -35.5 to -21.7

SECONDARY outcome

Timeframe: 4 weeks from Baseline (period following first 7 days of 2-week run-in period)

Population: The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.

Change from Baseline in the frequency of MSVS (difference between Baseline [period following first 7 days of 2-week run-in period] and period following first 7 days of 2-week Week 4 period), where the Baseline MSVS frequency was captured at visit 3 (Day 0), in the period following the first 7 days, as per CRF. Note: this endpoint is identical to the primary endpoint, however, instead of a 14 ± 2 day period, the period following the first 7 days was used, at Baseline and visit 3.

Treatment group differences are estimated using least squares (LS) means and 95% confidence intervals based on the mean square error from the ANCOVA. LSMeans refer to overall adjusted mean frequency of MSVS.

Outcome measures

Measure	S-equol 10 mg BID n=42 Participants 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 Participants 100 mg total daily dose of S-equol	S-equol 150 mg BID n=41 Participants 300 mg total daily dose of S-equol	Placebo n=42 Participants Placebo treatment arm
Mean Change in Frequency of MSVS From Baseline at Week 4 (1-week Period) Baseline (Day 0)	73.0 Number of MSVS/week Interval 64.3 to 81.7	71.4 Number of MSVS/week Interval 65.4 to 77.4	69.5 Number of MSVS/week Interval 62.0 to 76.9	67.9 Number of MSVS/week Interval 60.1 to 75.6
Mean Change in Frequency of MSVS From Baseline at Week 4 (1-week Period) Week 4	40.0 Number of MSVS/week Interval 27.5 to 52.5	45.5 Number of MSVS/week Interval 36.3 to 54.6	37.1 Number of MSVS/week Interval 28.2 to 46.1	40.2 Number of MSVS/week Interval 31.5 to 48.9
Mean Change in Frequency of MSVS From Baseline at Week 4 (1-week Period) Change from Baseline at Week 4	-30.2 Number of MSVS/week Interval -40.9 to -19.6	-24.9 Number of MSVS/week Interval -35.0 to -14.8	-32.6 Number of MSVS/week Interval -41.1 to -24.0	-27.6 Number of MSVS/week Interval -35.3 to -20.0
Mean Change in Frequency of MSVS From Baseline at Week 4 (1-week Period) LSMean	40.04 Number of MSVS/week Interval 31.02 to 49.06	44.99 Number of MSVS/week Interval 36.5 to 53.49	38.60 Number of MSVS/week Interval 30.09 to 47.1	40.23 Number of MSVS/week Interval 32.0 to 48.45

SECONDARY outcome

Timeframe: 1 and 2 weeks from Baseline (Day 0)

Population: The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.

The frequency of MSVS per week, at each of the protocol visits, was calculated as follows, for each patient: [# of Moderate+Severe hot flushes)/(Current protocol visit date-Previous protocol visit date (days)] * 7.

The ANCOVA procedure tested the following hypotheses:

H0: μ1 = μp versus HA: μ1 ≠ μp, where μ1 and μp denote the mean frequency of MSVS, adjusted for Baseline MSVS values, in the treatment and placebo groups, respectively.

LSMeans refer to the overall adjusted mean frequecy of MSVS.

Outcome measures

Measure	S-equol 10 mg BID n=42 Participants 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 Participants 100 mg total daily dose of S-equol	S-equol 150 mg BID n=41 Participants 300 mg total daily dose of S-equol	Placebo n=42 Participants Placebo treatment arm
Change From Baseline (Day 0) in the Frequency of MSVS at Week 1 and Week 2 Week 1	53.6 Number of MSVS/week Interval 47.4 to 59.8	63.1 Number of MSVS/week Interval 55.5 to 70.8	54.4 Number of MSVS/week Interval 45.0 to 63.7	54.1 Number of MSVS/week Interval 46.6 to 61.6
Change From Baseline (Day 0) in the Frequency of MSVS at Week 1 and Week 2 Change from Baseline at Week 1	-19.9 Number of MSVS/week Interval -28.6 to -11.2	-6.7 Number of MSVS/week Interval -12.7 to -0.7	-15.9 Number of MSVS/week Interval -21.6 to -10.2	-13.8 Number of MSVS/week Interval -18.8 to -8.8
Change From Baseline (Day 0) in the Frequency of MSVS at Week 1 and Week 2 Change from Baseline at Week 2	-23.3 Number of MSVS/week Interval -31.2 to -15.3	-14.8 Number of MSVS/week Interval -25.0 to -4.6	-19.4 Number of MSVS/week Interval -26.6 to -12.2	-17.9 Number of MSVS/week Interval -25.5 to -10.2
Change From Baseline (Day 0) in the Frequency of MSVS at Week 1 and Week 2 Week 1, LSMean	50.95 Number of MSVS/week Interval 44.67 to 57.24	64.41 Number of MSVS/week Interval 58.04 to 70.78	56.03 Number of MSVS/week Interval 49.52 to 62.55	54.72 Number of MSVS/week Interval 48.38 to 61.06
Change From Baseline (Day 0) in the Frequency of MSVS at Week 1 and Week 2 Week 2	47.3 Number of MSVS/week Interval 38.5 to 56.2	54.3 Number of MSVS/week Interval 44.2 to 64.4	51.0 Number of MSVS/week Interval 40.7 to 61.2	50.0 Number of MSVS/week Interval 41.4 to 58.7
Change From Baseline (Day 0) in the Frequency of MSVS at Week 1 and Week 2 Week 2, LSMean	43.96 Number of MSVS/week Interval 35.67 to 52.24	54.22 Number of MSVS/week Interval 45.97 to 62.47	51.56 Number of MSVS/week Interval 43.21 to 59.92	50.66 Number of MSVS/week Interval 42.45 to 58.87

SECONDARY outcome

Timeframe: 1, 2, and 4 weeks from Baseline (Day 0)

Population: The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.

The severity of vasomotor symptoms per week at each of the protocol visits was calculated for each patient as follows: [(Sum of scores of Mild, Moderate, Severe hot flushes)/(Current protocol visit date - Previous protocol visit date (days)] * 7, where severity of vasomotor symptoms were scored as: 1 = mild, 2 = moderate and 3 = severe. Higher values represented worse severity.

LSMeans refer to the overall adjusted mean severity of VMS.

Hot Flush Classification: Mild: sensation of heat without sweating; Moderate: sensation of heat with sweating, able to continue activity; Severe: sensation of heat with sweating, causing cessation of activity.

Patients recorded the number of hot flushes (day and night) in their diaries related to the severity (mild/moderate/severe).

Outcome measures

Measure	S-equol 10 mg BID n=42 Participants 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 Participants 100 mg total daily dose of S-equol	S-equol 150 mg BID n=41 Participants 300 mg total daily dose of S-equol	Placebo n=42 Participants Placebo treatment arm
Change From Baseline (Day 0) in the Severity of VMS as Recorded in the Patient Diary at Week 1, Week 2, and Week 4 Change from Baseline at Week 2	-60.4 units on a scale Interval -79.2 to -41.7	-35.3 units on a scale Interval -60.4 to -10.2	-49.4 units on a scale Interval -67.3 to -31.6	-44.1 units on a scale Interval -62.1 to -26.2
Change From Baseline (Day 0) in the Severity of VMS as Recorded in the Patient Diary at Week 1, Week 2, and Week 4 Week 1, LSMean	130.93 units on a scale Interval 116.79 to 145.07	162.94 units on a scale Interval 148.61 to 177.26	139.36 units on a scale Interval 124.72 to 153.99	137.27 units on a scale Interval 123.02 to 151.52
Change From Baseline (Day 0) in the Severity of VMS as Recorded in the Patient Diary at Week 1, Week 2, and Week 4 Baseline (Day 0)	188.6 units on a scale Interval 168.1 to 209.1	177.1 units on a scale Interval 161.0 to 193.2	175.6 units on a scale Interval 158.8 to 192.4	172.8 units on a scale Interval 155.9 to 189.7
Change From Baseline (Day 0) in the Severity of VMS as Recorded in the Patient Diary at Week 1, Week 2, and Week 4 Week 1	139.0 units on a scale Interval 123.1 to 155.0	160.4 units on a scale Interval 139.5 to 181.3	133.6 units on a scale Interval 113.9 to 153.4	136.0 units on a scale Interval 116.8 to 155.1
Change From Baseline (Day 0) in the Severity of VMS as Recorded in the Patient Diary at Week 1, Week 2, and Week 4 Change from Baseline at Week 1	-49.5 units on a scale Interval -66.7 to -32.4	-17.5 units on a scale Interval -32.6 to -2.5	-41.8 units on a scale Interval -55.8 to -27.8	-36.8 units on a scale Interval -48.3 to -25.4
Change From Baseline (Day 0) in the Severity of VMS as Recorded in the Patient Diary at Week 1, Week 2, and Week 4 Week 2	122.0 units on a scale Interval 99.5 to 144.5	140.1 units on a scale Interval 114.3 to 165.9	126.2 units on a scale Interval 102.7 to 149.6	128.7 units on a scale Interval 106.3 to 151.1
Change From Baseline (Day 0) in the Severity of VMS as Recorded in the Patient Diary at Week 1, Week 2, and Week 4 Week 2, LSMean	113.86 units on a scale Interval 94.57 to 133.14	138.73 units on a scale Interval 119.57 to 157.89	129.34 units on a scale Interval 109.92 to 148.77	130.00 units on a scale Interval 110.89 to 149.1
Change From Baseline (Day 0) in the Severity of VMS as Recorded in the Patient Diary at Week 1, Week 2, and Week 4 Week 4	110.5 units on a scale Interval 83.4 to 137.7	120.3 units on a scale Interval 98.0 to 142.6	99.5 units on a scale Interval 78.8 to 120.3	101.6 units on a scale Interval 83.1 to 120.1
Change From Baseline (Day 0) in the Severity of VMS as Recorded in the Patient Diary at Week 1, Week 2, and Week 4 Change from Baseline at Week 4	-75.5 units on a scale Interval -98.0 to -53.0	-56.8 units on a scale Interval -80.8 to -32.7	-76.2 units on a scale Interval -94.9 to -57.5	-71.2 units on a scale Interval -87.8 to -54.5
Change From Baseline (Day 0) in the Severity of VMS as Recorded in the Patient Diary at Week 1, Week 2, and Week 4 Week 4, LSMean	101.27 units on a scale Interval 81.98 to 120.56	119.11 units on a scale Interval 100.23 to 137.99	101.67 units on a scale Interval 82.39 to 120.94	102.96 units on a scale Interval 84.08 to 121.84

SECONDARY outcome

Timeframe: 2 and 4 weeks from Baseline (Day 0)

Population: The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.

The pH scale measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic. The pH scale is logarithmic and as a result, each whole pH value below 7 is ten times more acidic than the next higher value.

Normal vaginal pH is 3.8 to 4.5, slightly acidic.

The LSMeans refer to overall adjusted mean pH.

Outcome measures

Measure	S-equol 10 mg BID n=42 Participants 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 Participants 100 mg total daily dose of S-equol	S-equol 150 mg BID n=41 Participants 300 mg total daily dose of S-equol	Placebo n=42 Participants Placebo treatment arm
Change From Baseline (Day 0) in Vaginal pH at Week 2 and Week 4 Week 2, LSMean	5.51 units on a scale Interval 5.28 to 5.75	5.49 units on a scale Interval 5.27 to 5.72	5.75 units on a scale Interval 5.53 to 5.98	5.72 units on a scale Interval 5.49 to 5.94
Change From Baseline (Day 0) in Vaginal pH at Week 2 and Week 4 Baseline (Day 0)	5.5 units on a scale Interval 5.3 to 5.8	5.5 units on a scale Interval 5.3 to 5.8	5.8 units on a scale Interval 5.7 to 6.0	5.7 units on a scale Interval 5.5 to 6.0
Change From Baseline (Day 0) in Vaginal pH at Week 2 and Week 4 Week 2	5.4 units on a scale Interval 5.2 to 5.6	5.4 units on a scale Interval 5.2 to 5.6	5.8 units on a scale Interval 5.5 to 6.1	5.8 units on a scale Interval 5.5 to 6.0
Change From Baseline (Day 0) in Vaginal pH at Week 2 and Week 4 Change from Baseline at Week 2	-0.1 units on a scale Interval -0.3 to 0.1	-0.1 units on a scale Interval -0.3 to 0.1	-0.0 units on a scale Interval -0.3 to 0.3	0.0 units on a scale Interval -0.2 to 0.3
Change From Baseline (Day 0) in Vaginal pH at Week 2 and Week 4 Week 4	5.4 units on a scale Interval 5.1 to 5.7	5.5 units on a scale Interval 5.3 to 5.8	5.6 units on a scale Interval 5.4 to 5.8	5.8 units on a scale Interval 5.5 to 6.1
Change From Baseline (Day 0) in Vaginal pH at Week 2 and Week 4 Change from Baseline at Week 4	-0.2 units on a scale Interval -0.4 to 0.1	-0.0 units on a scale Interval -0.2 to 0.2	-0.3 units on a scale Interval -0.5 to -0.1	0.0 units on a scale Interval -0.2 to 0.2
Change From Baseline (Day 0) in Vaginal pH at Week 2 and Week 4 Week 4, LSMean	5.48 units on a scale Interval 5.28 to 5.68	5.61 units on a scale Interval 5.42 to 5.8	5.50 units on a scale Interval 5.3 to 5.69	5.74 units on a scale Interval 5.55 to 5.93

SECONDARY outcome

Timeframe: 2 and 4 weeks from Baseline (Day 0)

Population: The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.

The Vaginal Maturation Index was calculated by examining the maturation of the vaginal epithelium as adjudged by the cell types exfoliated. Parabasal cells are the least mature cells, intermediate cells display mild maturation, and superficial cells display the most maturity. The cell count is expressed as a percentage. The Vaginal Maturation Index was calculated as: 0.2*(parabasal cells, %)+0.6*(intermediate cells, %)+1.0*(superficial cells, %). This method is described in Menopause 2005;12(6):708-15.

The index serves as an objective means of evaluating hormonal secretion or response; lower values indicate more immature cells on the surface (atrophy), while higher values indicate more mature epithelium.

The LSMeans refer to overall adjusted mean percent of cells counted.

Outcome measures

Measure	S-equol 10 mg BID n=42 Participants 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 Participants 100 mg total daily dose of S-equol	S-equol 150 mg BID n=41 Participants 300 mg total daily dose of S-equol	Placebo n=42 Participants Placebo treatment arm
Change From Baseline in Vaginal Maturation Index at Week 2 and Week 4 Week 2, LSMean	50.89 percentage of cells Interval 45.29 to 56.5	50.89 percentage of cells Interval 45.2 to 56.58	50.88 percentage of cells Interval 45.09 to 56.67	52.47 percentage of cells Interval 46.8 to 58.14
Change From Baseline in Vaginal Maturation Index at Week 2 and Week 4 Baseline (Day 0)	52.6 percentage of cells Interval 47.4 to 57.9	55.7 percentage of cells Interval 50.7 to 60.7	50.9 percentage of cells Interval 44.7 to 57.2	43.5 percentage of cells Interval 37.4 to 49.6
Change From Baseline in Vaginal Maturation Index at Week 2 and Week 4 Week 2	54.5 percentage of cells Interval 49.0 to 60.1	54.3 percentage of cells Interval 47.4 to 61.1	50.8 percentage of cells Interval 43.1 to 58.6	47.0 percentage of cells Interval 41.0 to 52.9
Change From Baseline in Vaginal Maturation Index at Week 2 and Week 4 Change from Baseline at Week 2	-0.7 percentage of cells Interval -3.8 to 2.4	-1.3 percentage of cells Interval -8.4 to 5.9	0.6 percentage of cells Interval -6.5 to 7.7	3.9 percentage of cells Interval -3.0 to 10.8
Change From Baseline in Vaginal Maturation Index at Week 2 and Week 4 Week 4	56.5 percentage of cells Interval 50.8 to 62.2	51.7 percentage of cells Interval 45.5 to 57.9	51.3 percentage of cells Interval 45.2 to 57.5	48.1 percentage of cells Interval 42.2 to 54.0
Change From Baseline in Vaginal Maturation Index at Week 2 and Week 4 Change from Baseline at Week 4	1.7 percentage of cells Interval -2.1 to 5.5	-3.7 percentage of cells Interval -7.0 to -0.3	0.3 percentage of cells Interval -4.6 to 5.2	5.2 percentage of cells Interval -0.8 to 11.3
Change From Baseline in Vaginal Maturation Index at Week 2 and Week 4 Week 4, LSMean	53.58 percentage of cells Interval 48.92 to 58.24	47.75 percentage of cells Interval 43.35 to 52.14	51.01 percentage of cells Interval 46.62 to 55.4	53.26 percentage of cells Interval 49.52 to 58.26

SECONDARY outcome

Timeframe: 2 and 4 weeks from Baseline (Day 0)

Population: The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.

The LSMeans refer to overall adjusted mean estradiol concentration.

Outcome measures

Measure	S-equol 10 mg BID n=42 Participants 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 Participants 100 mg total daily dose of S-equol	S-equol 150 mg BID n=41 Participants 300 mg total daily dose of S-equol	Placebo n=42 Participants Placebo treatment arm
Change From Baseline in Estradiol Concentration at Weeks 2 and 4 Week 4, LSMean	100.89 Estradiol Concentration (pmol/L) Interval 67.96 to 133.81	86.56 Estradiol Concentration (pmol/L) Interval 54.78 to 118.34	56.03 Estradiol Concentration (pmol/L) Interval 24.14 to 87.91	78.77 Estradiol Concentration (pmol/L) Interval 47.31 to 110.23
Change From Baseline in Estradiol Concentration at Weeks 2 and 4 Baseline (Day 0)	79.0 Estradiol Concentration (pmol/L) Interval 55.5 to 102.5	65.7 Estradiol Concentration (pmol/L) Interval 53.8 to 77.6	66.1 Estradiol Concentration (pmol/L) Interval 53.1 to 79.2	59.6 Estradiol Concentration (pmol/L) Interval 50.2 to 69.1
Change From Baseline in Estradiol Concentration at Weeks 2 and 4 Week 2	117.3 Estradiol Concentration (pmol/L) Interval 69.4 to 165.2	72.2 Estradiol Concentration (pmol/L) Interval 54.4 to 90.1	68.1 Estradiol Concentration (pmol/L) Interval 51.0 to 85.2	62.1 Estradiol Concentration (pmol/L) Interval 51.1 to 73.1
Change From Baseline in Estradiol Concentration at Weeks 2 and 4 Change from Baseline at Week 2	40.2 Estradiol Concentration (pmol/L) Interval -2.4 to 82.9	6.7 Estradiol Concentration (pmol/L) Interval -10.3 to 23.7	2.0 Estradiol Concentration (pmol/L) Interval -9.0 to 12.9	2.5 Estradiol Concentration (pmol/L) Interval -4.5 to 9.5
Change From Baseline in Estradiol Concentration at Weeks 2 and 4 Week 2, LSMean	104.93 Estradiol Concentration (pmol/L) Interval 81.11 to 128.76	73.22 Estradiol Concentration (pmol/L) Interval 49.98 to 96.46	65.03 Estradiol Concentration (pmol/L) Interval 41.8 to 88.26	69.61 Estradiol Concentration (pmol/L) Interval 46.24 to 92.99
Change From Baseline in Estradiol Concentration at Weeks 2 and 4 Week 4	114.0 Estradiol Concentration (pmol/L) Interval 48.1 to 179.9	82.8 Estradiol Concentration (pmol/L) Interval 45.5 to 120.1	60.0 Estradiol Concentration (pmol/L) Interval 45.2 to 74.7	70.4 Estradiol Concentration (pmol/L) Interval 40.0 to 100.8
Change From Baseline in Estradiol Concentration at Weeks 2 and 4 Change from Baseline at Week 4	37.5 Estradiol Concentration (pmol/L) Interval -8.4 to 83.4	20.3 Estradiol Concentration (pmol/L) Interval -18.5 to 59.2	-6.7 Estradiol Concentration (pmol/L) Interval -19.1 to 5.6	10.7 Estradiol Concentration (pmol/L) Interval -18.3 to 39.8

SECONDARY outcome

Timeframe: 2 and 4 weeks from Baseline (Day 0)

Population: The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.

No repeated measures ANCOVA results are presented for change from Baseline in progesterone concentrations since the model did not converge.

Outcome measures

Measure	S-equol 10 mg BID n=42 Participants 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 Participants 100 mg total daily dose of S-equol	S-equol 150 mg BID n=41 Participants 300 mg total daily dose of S-equol	Placebo n=42 Participants Placebo treatment arm
Change From Baseline in Progesterone Concentration at Week 2 and Week 4 Change from Baseline at Week 2	0.0 Progesterone Concentration (nmol/L) Interval -0.1 to 0.1	0.1 Progesterone Concentration (nmol/L) Interval 0.0 to 0.3	-0.2 Progesterone Concentration (nmol/L) Interval -0.6 to 0.1	-0.0 Progesterone Concentration (nmol/L) Interval -0.1 to 0.0
Change From Baseline in Progesterone Concentration at Week 2 and Week 4 Baseline (Day 0)	1.1 Progesterone Concentration (nmol/L) Interval 1.0 to 1.3	1.1 Progesterone Concentration (nmol/L) Interval 0.9 to 1.3	1.3 Progesterone Concentration (nmol/L) Interval 0.9 to 1.6	1.1 Progesterone Concentration (nmol/L) Interval 0.9 to 1.3
Change From Baseline in Progesterone Concentration at Week 2 and Week 4 Week 2	1.2 Progesterone Concentration (nmol/L) Interval 1.0 to 1.3	1.3 Progesterone Concentration (nmol/L) Interval 1.0 to 1.5	1.1 Progesterone Concentration (nmol/L) Interval 0.9 to 1.2	1.0 Progesterone Concentration (nmol/L) Interval 0.9 to 1.2
Change From Baseline in Progesterone Concentration at Week 2 and Week 4 Week 4	7.0 Progesterone Concentration (nmol/L) Interval -4.8 to 18.9	1.1 Progesterone Concentration (nmol/L) Interval 0.9 to 1.2	1.4 Progesterone Concentration (nmol/L) Interval 0.8 to 2.0	1.1 Progesterone Concentration (nmol/L) Interval 0.9 to 1.2
Change From Baseline in Progesterone Concentration at Week 2 and Week 4 Change from Baseline at Week 4	5.9 Progesterone Concentration (nmol/L) Interval -5.9 to 17.8	-0.0 Progesterone Concentration (nmol/L) Interval -0.1 to 0.0	0.1 Progesterone Concentration (nmol/L) Interval -0.2 to 0.4	-0.0 Progesterone Concentration (nmol/L) Interval -0.1 to 0.0

SECONDARY outcome

Timeframe: 4 weeks from Baseline (Day 0)

Population: The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.

MRS consists of 11 menopause symptoms. The scoring scheme is simple, i.e., the score increases point by point with increasing severity of subjectively perceived symptoms in each of the 11 items (severity 0 [no complaints] 4 scoring points [extremely severe symptoms]). The respondent provides her personal perception by checking one of 5 possible boxes of "severity" for each of the items. The composite score (total score) is the sum of the 11 item scores, which can range from 0 (no symptoms) to 44 (extremely severe symptoms). Low total scores represent less severe menopause symptoms while higher scores represent more severe symptoms.

Outcome measures

Measure	S-equol 10 mg BID n=42 Participants 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 Participants 100 mg total daily dose of S-equol	S-equol 150 mg BID n=41 Participants 300 mg total daily dose of S-equol	Placebo n=42 Participants Placebo treatment arm
Mean Change in the Menopause Rating Scale Total Score From Baseline at Week 4 Baseline (Day 0)	16.9 units on a scale Interval 14.3 to 19.5	17.3 units on a scale Interval 14.6 to 20.1	15.7 units on a scale Interval 13.3 to 18.1	14.5 units on a scale Interval 12.6 to 16.4
Mean Change in the Menopause Rating Scale Total Score From Baseline at Week 4 Week 4	11.5 units on a scale Interval 8.7 to 14.2	10.8 units on a scale Interval 8.5 to 13.1	9.7 units on a scale Interval 7.7 to 11.7	9.9 units on a scale Interval 8.3 to 11.6
Mean Change in the Menopause Rating Scale Total Score From Baseline at Week 4 Change from Baseline at Week 4	-5.3 units on a scale Interval -7.0 to 3.7	-6.4 units on a scale Interval -8.3 to 4.4	-6.0 units on a scale Interval -8.5 to 3.6	-4.6 units on a scale Interval -6.4 to 2.8

SECONDARY outcome

Timeframe: 4 weeks from Baseline (Day 0)

Population: The analysis population consists of all randomized patients who received at least 1 dose of randomized study drug starting at visit 3, who had at least 1 post-dose efficacy assessment. Missing efficacy data were not imputed.

Percentage change from Baseline at Week 4 = (Week 4 value - Day 0 value)/(Day 0 value) x 100. Note: MRS consists of 11 symptoms, where each symptom is assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe').

Outcome measures

Measure	S-equol 10 mg BID n=42 Participants 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 Participants 100 mg total daily dose of S-equol	S-equol 150 mg BID n=41 Participants 300 mg total daily dose of S-equol	Placebo n=42 Participants Placebo treatment arm
Mean Precentage Change in the Menopause Rating Scale Total Score From Baseline at Week 4	-36.7 Percentage Change Interval -46.8 to -26.6	-37.4 Percentage Change Interval -46.9 to -27.9	-30.6 Percentage Change Interval -43.8 to -17.4	-27.4 Percentage Change Interval -39.2 to 15.6

POST_HOC outcome

Timeframe: 4 weeks from Baseline (Day 0)

Note: Each MRS symptoms is assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe').

Scores for Symptoms 5, 10, and 11 on the MRS were summed and analyzed. Total summed scores ranged from 0 to 12, with higher scores representing more severe symptoms.

Outcome measures

Measure	S-equol 10 mg BID n=42 Participants 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 Participants 100 mg total daily dose of S-equol	S-equol 150 mg BID n=41 Participants 300 mg total daily dose of S-equol	Placebo n=42 Participants Placebo treatment arm
Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort) Baseline (Day 0)	4.0 units on a scale Interval 3.2 to 4.9	4.2 units on a scale Interval 3.3 to 5.2	4.0 units on a scale Interval 3.2 to 4.8	3.4 units on a scale Interval 2.8 to 4.0
Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort) Change from Baseline at Week 4	-1.3 units on a scale Interval -1.9 to -0.7	-1.5 units on a scale Interval -2.3 to -0.8	-1.5 units on a scale Interval -2.2 to -0.7	-0.5 units on a scale Interval -1.1 to 0.1
Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort) Week 4	2.8 units on a scale Interval 2.0 to 3.7	2.8 units on a scale Interval 2.1 to 3.6	2.5 units on a scale Interval 1.9 to 3.2	2.9 units on a scale Interval 2.3 to 3.5

POST_HOC outcome

Timeframe: 4 weeks from Baseline (Day 0)

Percentage change from Baseline at Week 4 = (Week 4 value - Day 0 value)/(Day 0 value) x 100. Note: Each MRS symptoms is assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe').

Outcome measures

Measure	S-equol 10 mg BID n=42 Participants 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 Participants 100 mg total daily dose of S-equol	S-equol 150 mg BID n=41 Participants 300 mg total daily dose of S-equol	Placebo n=42 Participants Placebo treatment arm
Percentage Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort)	-29.1 Percentage Change Interval -49.5 to -8.7	-32.7 Percentage Change Interval -50.6 to -14.8	-30.2 Percentage Change Interval -49.6 to -10.9	-0.6 Percentage Change Interval -23.2 to 21.9

POST_HOC outcome

Timeframe: 4 weeks from Baseline (Day 0)

The following analysis shows the results when the S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) are combined and regarded as a single treatment group.

Note: Each MRS symptoms was assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe'

Outcome measures

Measure	S-equol 10 mg BID n=125 Participants 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 Participants 100 mg total daily dose of S-equol	S-equol 150 mg BID 300 mg total daily dose of S-equol	Placebo Placebo treatment arm
Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort) - S-equol Groups Combined Week 4	2.7 units on a scale Interval 2.3 to 3.2	2.9 units on a scale Interval 2.3 to 3.5	—	—
Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort) - S-equol Groups Combined Change from Baseline at Week 4	-1.4 units on a scale Interval -1.8 to -1.0	0.0 units on a scale Interval -1.1 to 0.1	—	—
Change From Baseline in Menopause Rating Scale (MRS) - Sum of 3 Symptoms (Irritability, Dry Vagina, Joint/Muscular Discomfort) - S-equol Groups Combined Baseline (Day 0)	4.1 units on a scale Interval 3.6 to 4.6	3.4 units on a scale Interval 2.8 to 4.0	—	—

POST_HOC outcome

Timeframe: 4 weeks from Baseline (Day 0)

The following analysis pre-specified the combining of all S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) into a single treatment group. The results from the Wilcoxon-Mann-Whitney test (pair-wise test), based on the change from Baseline at Week 4, are presented.

Note: Dryness of Vagina was assigned a score from 0 to 4 (0 = 'None' and 4 = 'Extremely severe'

Outcome measures

Measure	S-equol 10 mg BID n=125 Participants 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 Participants 100 mg total daily dose of S-equol	S-equol 150 mg BID 300 mg total daily dose of S-equol	Placebo Placebo treatment arm
Change From Baseline in Menopause Rating Scale (MRS) - Dryness of Vagina- S-equol Groups Combined Baseline (Day 0)	1.5 units on a scale Interval 1.2 to 1.7	1.5 units on a scale Interval 1.1 to 1.9	—	—
Change From Baseline in Menopause Rating Scale (MRS) - Dryness of Vagina- S-equol Groups Combined Week 4	1.1 units on a scale Interval 0.8 to 1.3	1.4 units on a scale Interval 1.0 to 1.8	—	—
Change From Baseline in Menopause Rating Scale (MRS) - Dryness of Vagina- S-equol Groups Combined Change from Baseline at Week 4	-0.4 units on a scale Interval -0.6 to -0.3	-0.1 units on a scale Interval -0.4 to 0.2	—	—

Adverse Events

S-equol 10 mg BID

Serious events: 1 serious events

Other events: 20 other events

Deaths: 0 deaths

S-equol 50 mg BID

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

S-equol 150 mg BID

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	S-equol 10 mg BID n=43 participants at risk 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 participants at risk 100 mg total daily dose of S-equol	S-equol 150 mg BID n=42 participants at risk 300 mg total daily dose of S-equol	Placebo n=42 participants at risk Placebo treatment arm
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Respiratory, thoracic and mediastinal disorders Pleurisy	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.

Other adverse events

Measure	S-equol 10 mg BID n=43 participants at risk 20 mg total daily dose of S-equol	S-equol 50 mg BID n=42 participants at risk 100 mg total daily dose of S-equol	S-equol 150 mg BID n=42 participants at risk 300 mg total daily dose of S-equol	Placebo n=42 participants at risk Placebo treatment arm
Cardiac disorders Atrial Fibrillation	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Cardiac disorders Cardiac Disorder	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Eye disorders Conjunctivitis	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Gastrointestinal disorders Abdominal Distension	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Gastrointestinal disorders Abdominal Pain	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Gastrointestinal disorders Abdominal Pain Upper	2.3% 1/43 • Number of events 2 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Gastrointestinal disorders Abnormal Feces	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Gastrointestinal disorders Constipation	9.3% 4/43 • Number of events 4 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Gastrointestinal disorders Diarrhea	7.0% 3/43 • Number of events 3 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Gastrointestinal disorders Dry Mouth	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Gastrointestinal disorders Dyspepsia	4.7% 2/43 • Number of events 2 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	7.1% 3/42 • Number of events 3 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Gastrointestinal disorders Flatulence	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Gastrointestinal disorders Hemorrhoids	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Gastrointestinal disorders Nausea	11.6% 5/43 • Number of events 7 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	7.1% 3/42 • Number of events 3 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	7.1% 3/42 • Number of events 3 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Gastrointestinal disorders Toothache	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Gastrointestinal disorders Vomiting	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
General disorders Asthenia	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
General disorders Chest Pain	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
General disorders Fatigue	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
General disorders Injection Site Pain	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
General disorders Irritability	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
General disorders Immune System Disorders	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
General disorders Seasonal Allergy	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Infections and infestations Fungal Infection	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Infections and infestations Gastroenteritis	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Infections and infestations Gingival Infection	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Infections and infestations Influenza	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Infections and infestations Lower Respiratory Tract Infection	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Infections and infestations Nail Infection	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Infections and infestations Nasopharyngitis	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Infections and infestations Oral Herpes	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Infections and infestations Rhinitis	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Infections and infestations Sinusitis	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Infections and infestations Upper Respiratory Tract Infection	4.7% 2/43 • Number of events 2 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	4.8% 2/42 • Number of events 2 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	14.3% 6/42 • Number of events 6 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	4.8% 2/42 • Number of events 2 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Infections and infestations Urinary Tract Infection	4.7% 2/43 • Number of events 2 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	4.8% 2/42 • Number of events 2 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	7.1% 3/42 • Number of events 3 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Infections and infestations Vaginal Infection	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Injury, poisoning and procedural complications Arthropod Bite	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 2 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Injury, poisoning and procedural complications Contusion	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Injury, poisoning and procedural complications Joint Sprain	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Injury, poisoning and procedural complications Mouth Injury	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Injury, poisoning and procedural complications Muscle Strain	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Injury, poisoning and procedural complications Procedural Hypertension	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Investigations Alanine Aminotransferase Increased	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Investigations Blood Glucose Increased	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Investigations Blood Lactate Dehydrogenase Increased	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Investigations Blood Triglycerides Increased	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Investigations Estradiol Increased	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Investigations Smear Cervix Abnormal	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Musculoskeletal and connective tissue disorders Arthralgia	4.7% 2/43 • Number of events 2 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	4.8% 2/42 • Number of events 2 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Nervous system disorders Dizziness	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Nervous system disorders Headache	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	7.1% 3/42 • Number of events 3 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	4.8% 2/42 • Number of events 2 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Nervous system disorders Migraine	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Nervous system disorders Sciatica	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Psychiatric disorders Anxiety	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Psychiatric disorders Insomnia	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Psychiatric disorders Mood Swings	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Renal and urinary disorders Glycosuria	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Reproductive system and breast disorders Breast Tenderness	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Reproductive system and breast disorders Cervical Dysplasia	2.3% 1/43 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Reproductive system and breast disorders Endometrial Hypertrophy	4.7% 2/43 • Number of events 2 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	7.1% 3/42 • Number of events 3 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Reproductive system and breast disorders Vaginal Discharge	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Reproductive system and breast disorders Vaginal Hemorrhage	2.3% 1/43 • Number of events 2 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Reproductive system and breast disorders Vulvovaginal Erythema	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Respiratory, thoracic and mediastinal disorders Dry Throat	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Skin and subcutaneous tissue disorders Actinic Keratosis	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Skin and subcutaneous tissue disorders Dermatitis Contact	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Skin and subcutaneous tissue disorders Rash Macular	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Skin and subcutaneous tissue disorders Rash Pruritic	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Skin and subcutaneous tissue disorders Skin Hypertrophy	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.
Vascular disorders Hot Flush	0.00% 0/43 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	2.4% 1/42 • Number of events 1 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.	0.00% 0/42 • Adverse events were collected from the time of signing of the informed consent document through the follow-up visit or early termination visit (whichever occurred first). An adverse event was followed to a satisfactory resolution, until it became stable, or until it could be explained by another known cause(s) and clinical judgment indicated that further evaluation was not warranted, or 30 days from the date of last study drug dose for adverse events not related to study drug.

Additional Information

Rick Schwen, PhD, DABT, RAC / Vice President of Regulatory Affairs

Ausio Pharmaceuticals, LLC

Phone: 513-731-0222

Email: rick@ausiopharma.com

Results disclosure agreements

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

Restriction type: LTE60