Trial Outcomes & Findings for Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptomatic Endometriosis (NCT NCT01728454)

NCT ID: NCT01728454

Last Updated: 2019-07-23

Results Overview

The BBSS scale defined dysmenorrhea according to the loss of work efficiency and need for bed rest. The dysmenorrhea was graded on a scale from 0 to 3 where, 0 = None; 1 = Mild (some loss in work efficiency); 2 = Moderate (in bed part of the day, occasional loss of work efficiency); 3 = Severe (in bed one or more days, incapacitation), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)
• Results posted on: 2019-07-23

Participant Flow

Participant milestones

Measure	Placebo Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 milligrams (mg)/day separated by an off-drug interval (ODI) in Stage 3.	Telapristone Acetate 6 mg Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.	Telapristone Acetate 12 mg Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
Stage 1 and 2 STARTED	17	20	23
Stage 1 and 2 COMPLETED	12	16	19
Stage 1 and 2 NOT COMPLETED	5	4	4
Stage 3 STARTED	6	5	11
Stage 3 COMPLETED	3	1	7
Stage 3 NOT COMPLETED	3	4	4

Reasons for withdrawal

Measure	Placebo Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 milligrams (mg)/day separated by an off-drug interval (ODI) in Stage 3.	Telapristone Acetate 6 mg Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.	Telapristone Acetate 12 mg Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
Stage 1 and 2 Pregnancy	1	0	0
Stage 1 and 2 Non-compliance with Protocol	0	0	1
Stage 1 and 2 Moved to Active Drug/ Lack of Efficacy	1	0	0
Stage 1 and 2 Lost to Follow-up	1	1	0
Stage 1 and 2 Withdrew due to Adverse Events/Toxicity	2	3	3
Stage 3 Reason Missing	0	0	1
Stage 3 Subject Required Other Treatment	0	1	0
Stage 3 Pregnancy	1	0	0
Stage 3 Withdrew Consent	1	0	1
Stage 3 Non-compliance with Protocol	0	0	1
Stage 3 Lost to Follow-up	0	3	1
Stage 3 Withdrew due to Adverse Events/Toxicity	1	0	0

Baseline Characteristics

Safety and Efficacy of Telapristone Acetate (Proellex®) in the Treatment of Pre-Menopausal Women With Confirmed, Symptomatic Endometriosis

Baseline characteristics by cohort

Measure	Placebo n=17 Participants Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.	Telapristone Acetate 6 mg n=20 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.	Telapristone Acetate 12 mg n=23 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.	Total n=60 Participants Total of all reporting groups
Age, Continuous	28.3 years STANDARD_DEVIATION 6.52 • n=5 Participants	30.8 years STANDARD_DEVIATION 5.93 • n=7 Participants	30.1 years STANDARD_DEVIATION 7.07 • n=5 Participants	29.8 years STANDARD_DEVIATION 6.52 • n=4 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	20 Participants n=7 Participants	23 Participants n=5 Participants	60 Participants n=4 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
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Race/Ethnicity, Customized White	15 Participants n=5 Participants	14 Participants n=7 Participants	18 Participants n=5 Participants	47 Participants n=4 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Race/Ethnicity, Customized Non-Hispanic or Non-Latino	12 Participants n=5 Participants	16 Participants n=7 Participants	18 Participants n=5 Participants	46 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)

Population: Intent-to-Treat (ITT) population included all participants who were randomized and received study drug.

The BBSS scale defined dysmenorrhea according to the loss of work efficiency and need for bed rest. The dysmenorrhea was graded on a scale from 0 to 3 where, 0 = None; 1 = Mild (some loss in work efficiency); 2 = Moderate (in bed part of the day, occasional loss of work efficiency); 3 = Severe (in bed one or more days, incapacitation), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=17 Participants Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.	Telapristone Acetate 6 mg n=20 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.	Telapristone Acetate 12 mg n=23 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea Baseline	12.6 score on a scale per 28-day period Standard Deviation 5.58	10.8 score on a scale per 28-day period Standard Deviation 6.90	11.1 score on a scale per 28-day period Standard Deviation 5.55
Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea Change from Baseline to On-Drug Cycle 1	-3.95 score on a scale per 28-day period Standard Deviation 5.936	-8.46 score on a scale per 28-day period Standard Deviation 5.174	-6.46 score on a scale per 28-day period Standard Deviation 10.668
Change From Baseline in Individual Biberoglu Behrman Symptom Severity Scale (BBSS) Score for Dysmenorrhea Change from Baseline to Off-Drug Cycle 1	-2.43 score on a scale per 28-day period Standard Deviation 7.852	1.36 score on a scale per 28-day period Standard Deviation 14.546	-1.82 score on a scale per 28-day period Standard Deviation 9.054

PRIMARY outcome

Timeframe: Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)

Population: ITT population included all participants who were randomized and received study drug.

The BBSS scale defined deep dyspareunia according to the limitation of sexual activity. The dyspareunia was graded on a scale from 0 to 3 where, 0= None (no discomfort); 1= Mild (tolerated discomfort); 2= Moderate (intercourse painful to the point of interruption); 3= Severe (intercourse avoided because of pain), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement..

Outcome measures

Measure	Placebo n=17 Participants Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.	Telapristone Acetate 6 mg n=20 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.	Telapristone Acetate 12 mg n=23 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
Change From Baseline in Individual BBSS Score for Dyspareunia Baseline	41.2 score on a scale per 28-day period Standard Deviation 24.15	36.5 score on a scale per 28-day period Standard Deviation 24.43	39.8 score on a scale per 28-day period Standard Deviation 21.42
Change From Baseline in Individual BBSS Score for Dyspareunia Change from Baseline to On-Drug Cycle 1	-21.50 score on a scale per 28-day period Standard Deviation 18.800	-14.75 score on a scale per 28-day period Standard Deviation 19.749	-9.83 score on a scale per 28-day period Standard Deviation 15.594
Change From Baseline in Individual BBSS Score for Dyspareunia Change from Baseline to Off-Drug Cycle 1	-21.50 score on a scale per 28-day period Standard Deviation 18.800	-14.75 score on a scale per 28-day period Standard Deviation 19.749	-9.83 score on a scale per 28-day period Standard Deviation 15.594

PRIMARY outcome

Timeframe: Baseline (28-day Baseline Menstrual Cycle) to the last day dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and to the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)

Population: ITT population included all participants who were randomized and received study drug.

The BBSS scale defined non-menstrual pelvic pain according to various degrees of discomfort and use of analgesics. The non-menstrual pelvic pain was graded on a scale from 0 to 3 where, 0= None (absence of pain); 1= Mild (occasional pelvic discomfort); 2= Moderate (noticeable discomfort for most of the cycle); 3= Severe (pain persisting during the cycle or requiring strong analgesics), with higher scores indicating more severe symptoms. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=17 Participants Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.	Telapristone Acetate 6 mg n=20 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.	Telapristone Acetate 12 mg n=23 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain Baseline	34.3 score on a scale per 28-day period Standard Deviation 18.07	33.5 score on a scale per 28-day period Standard Deviation 17.85	32.7 score on a scale per 28-day period Standard Deviation 16.68
Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain Change from Baseline to On-Drug Cycle 1	-6.06 score on a scale per 28-day period Standard Deviation 11.132	-10.01 score on a scale per 28-day period Standard Deviation 15.200	-2.96 score on a scale per 28-day period Standard Deviation 15.782
Change From Baseline in Individual BBSS Score for Non-Menstrual Pelvic Pain Change from Baseline to Off-Drug Cycle 1	-6.87 score on a scale per 28-day period Standard Deviation 12.034	-13.09 score on a scale per 28-day period Standard Deviation 17.745	-8.26 score on a scale per 28-day period Standard Deviation 13.608

SECONDARY outcome

Timeframe: Baseline (28-day Baseline Menstrual Cycle) to the last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)

Population: ITT population included all participants who were randomized and received study drug.

An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Prescription analgesics are analgesics prescribed by the physician. Participants were provided with a daily diary to record the number of pills of non-narcotic prescription and narcotic analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=17 Participants Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.	Telapristone Acetate 6 mg n=20 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.	Telapristone Acetate 12 mg n=23 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
Change From Baseline in Prescription Analgesics Usage Baseline	14.8 pills per 28-day period Standard Deviation 18.13	14.9 pills per 28-day period Standard Deviation 20.72	31.4 pills per 28-day period Standard Deviation 52.55
Change From Baseline in Prescription Analgesics Usage Change from Baseline to On-Drug Cycle	-6.74 pills per 28-day period Standard Deviation 14.897	-7.20 pills per 28-day period Standard Deviation 15.948	-5.87 pills per 28-day period Standard Deviation 27.753

SECONDARY outcome

Timeframe: Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)

Population: ITT population included all participants who were randomized and received study drug.

An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Prescription analgesics are analgesics prescribed by the physician. Participants were provided with a daily diary to record the number of pills of non-narcotic prescription and narcotic analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28.The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28 day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=17 Participants Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.	Telapristone Acetate 6 mg n=20 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.	Telapristone Acetate 12 mg n=23 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
Percentage Change From Baseline in Prescription Analgesics Usage	-9.69 percent change Standard Deviation 71.980	-21.63 percent change Standard Deviation 76.530	-6.36 percent change Standard Deviation 174.210

SECONDARY outcome

Timeframe: Baseline (28-day Baseline Menstrual Cycle) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)

Population: ITT population included all participants who were randomized and received study drug.

An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Nonprescription analgesics are over-the-counter (OTC) analgesics. Participants were provided with a daily diary to record the number of pills of OTC drugs taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=17 Participants Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.	Telapristone Acetate 6 mg n=20 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.	Telapristone Acetate 12 mg n=23 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
Change From Baseline in Non-Prescription Analgesics Usage Baseline	19.0 pills per 28-day period Standard Deviation 29.05	15.4 pills per 28-day period Standard Deviation 26.95	43.2 pills per 28-day period Standard Deviation 98.60
Change From Baseline in Non-Prescription Analgesics Usage Change from Baseline to On-Drug Cycle	1.78 pills per 28-day period Standard Deviation 21.426	-12.79 pills per 28-day period Standard Deviation 25.628	-6.81 pills per 28-day period Standard Deviation 25.615

SECONDARY outcome

Timeframe: Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)

Population: ITT population included all participants who were randomized and received study drug.

An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. Nonprescription analgesics are OTC analgesics. Participants were provided with a daily diary to record the number of pills of over the counter drugs taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28 day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change indicates improvement.

Outcome measures

Measure	Placebo n=17 Participants Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.	Telapristone Acetate 6 mg n=20 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.	Telapristone Acetate 12 mg n=23 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
Percentage Change From Baseline in Non-Prescription Analgesics Usage	6.06 percent change Standard Deviation 62.237	-22.80 percent change Standard Deviation 57.498	-31.49 percent change Standard Deviation 60.114

SECONDARY outcome

Timeframe: Baseline (28-day Baseline Menstrual Cycle) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)

Population: ITT Population consisted of all participants who were randomized and received study drug.

An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. The total analgesics is comprised of prescription and non-prescription analgesics. Participants were provided with a daily diary to record the number of pills of OTC and prescription analgesics taken for endometriosis-related pain symptoms each day. The daily number of pills were standardized to a 28-day period for each interval (Baseline and On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=17 Participants Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.	Telapristone Acetate 6 mg n=20 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.	Telapristone Acetate 12 mg n=23 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
Change From Baseline in Total Analgesics Usage Baseline	33.8 pills per 28-day period Standard Deviation 32.46	30.2 pills per 28-day period Standard Deviation 35.09	74.6 pills per 28-day period Standard Deviation 126.20
Change From Baseline in Total Analgesics Usage Change from Baseline to On-Drug Cycle	-4.96 pills per 28-day period Standard Deviation 12.525	-19.99 pills per 28-day period Standard Deviation 25.132	-12.67 pills per 28-day period Standard Deviation 38.865

SECONDARY outcome

Timeframe: Baseline (28-day Baseline Menstrual Cycle) to last 28 days of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks)

Population: ITT population included all participants who were randomized and received study drug.

An analgesic was any member of the group of drugs used to achieve analgesia, relief from pain. The total analgesics is comprised of prescription and non-prescription analgesics. Participants were provided with a daily diary to record the number of pills of OTC and prescription analgesics taken for endometriosis-related pain symptoms each day. Daily number of pills were standardized to a 28-day period for each interval (Baseline and last 28-days On-drug Cycle 1) calculated as the sum of pills in the interval divided by the number of the days in the interval multiplied by 28. The percent change from baseline in the analgesic usage was determined by subtracting the baseline analgesic usage from the analgesic usage during the last nominal 28-day menstrual cycle, divided by the baseline analgesic usage, and multiplied by 100%. A negative percent change indicates improvement.

Outcome measures

Measure	Placebo n=17 Participants Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.	Telapristone Acetate 6 mg n=20 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.	Telapristone Acetate 12 mg n=23 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
Percentage Change From Baseline in Total Analgesics Usage	-13.88 percent change Standard Deviation 64.098	-51.96 percent change Standard Deviation 45.461	-36.05 percent change Standard Deviation 57.129

SECONDARY outcome

Timeframe: Baseline (Day 1) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)

Population: ITT population included all participants who were randomized and received study drug. Last observation carried forward (LOCF) approach was used to impute missing data in this outcome measure.

BBSS Physician-Reported Scores included two scores: Pelvic Tenderness Score (PTS) and Induration Score (IS). PTS was graded on a scale from 0 to 3 where, 0= None; 1= Mild (minimal tenderness on palpation); 2= Moderate (extensive tenderness on palpation); 3= Severe (unable to palpate because of tenderness). IS was graded on a scale from 0 to 3 where, 0= None; 1= Mild (uterus freely mobile, induration on the cul-de-sac); 2= Moderate (thickened and indurated adnexa and cul-de-sac, restricted uterine mobility); 3= Severe (nodular adnexa and cul-de-sac, uterus frequently frozen), with higher scores indicating more severe symptoms. A negative change from Baseline indicates improvement. Data from On-drug cycle and Off-drug interval (ODI) were reported.

Outcome measures

Measure	Placebo n=17 Participants Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.	Telapristone Acetate 6 mg n=20 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.	Telapristone Acetate 12 mg n=23 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
Change From Baseline in BBSS Physician-Reported Scores PTS Change from BL to ODI Cycle 1	-0.92 score on a scale Standard Deviation 0.954	-0.59 score on a scale Standard Deviation 0.712	-0.18 score on a scale Standard Deviation 1.006
Change From Baseline in BBSS Physician-Reported Scores PTS at Baseline (BL)	1.9 score on a scale Standard Deviation 0.83	1.8 score on a scale Standard Deviation 0.77	1.5 score on a scale Standard Deviation 0.67
Change From Baseline in BBSS Physician-Reported Scores PTS Change from BL to LOCF Cycle 1	-0.76 score on a scale Standard Deviation 0.903	-0.95 score on a scale Standard Deviation 1.146	-0.43 score on a scale Standard Deviation 0.843
Change From Baseline in BBSS Physician-Reported Scores IS at Baseline	1.0 score on a scale Standard Deviation 1.06	1.1 score on a scale Standard Deviation 1.05	0.8 score on a scale Standard Deviation 0.83
Change From Baseline in BBSS Physician-Reported Scores IS Change from BL to LOCF Cycle 1	-0.53 score on a scale Standard Deviation 1.007	-0.70 score on a scale Standard Deviation 0.923	-0.39 score on a scale Standard Deviation 0.988
Change From Baseline in BBSS Physician-Reported Scores IS Change from BL to ODI Cycle 1	-0.54 score on a scale Standard Deviation 0.967	-0.59 score on a scale Standard Deviation 0.870	-0.41 score on a scale Standard Deviation 0.796

SECONDARY outcome

Timeframe: Baseline (Day 1) to last day of dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and at the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)

Population: ITT population included all participants who were randomized and received study drug.

A 100-millimeter (mm) VAS was used to grade the severity of dysmenorrhea, and non-menstrual pelvic pain. The lowest value indicated the absence of pain and the highest value indicated pain as bad as it could be; a score of 1-50 was considered mild pain, 51-80 moderate pain and 81-100 severe pain. A negative change from Baseline indicates improvement. Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain.

Outcome measures

Measure	Placebo n=17 Participants Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.	Telapristone Acetate 6 mg n=20 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.	Telapristone Acetate 12 mg n=23 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score Baseline	57.0 score on a scale Standard Deviation 27.68	66.6 score on a scale Standard Deviation 25.06	63.8 score on a scale Standard Deviation 29.14
Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score Percentage change from BL to LOCF Cycle 1	-30.11 score on a scale Standard Deviation 39.877	-46.10 score on a scale Standard Deviation 46.871	-17.02 score on a scale Standard Deviation 88.394
Change From Baseline in Participant-Reported Pain Using Visual Analog Scale (VAS) Pain Score Percent change from BL to ODI Cycle 1	-29.36 score on a scale Standard Deviation 46.552	-12.57 score on a scale Standard Deviation 52.070	118.34 score on a scale Standard Deviation 596.879

SECONDARY outcome

Timeframe: Baseline (28-day Baseline Menstrual Cycle) to the last day dosing in Cycle 1 (On-drug Cycle 1 is 18 weeks) and to the end of Off-drug Cycle 1 (Off-drug Cycle 1 is 3 weeks following On-drug Cycle 1)

Population: ITT population included all participants who were randomized and received study drug.

NRS is a valid and reliable clinical measure to assess pain intensity. Sex Avoidance Pain (SAP) and Endometriosis Pain (EP) were assessed using NRS-11 to measure pain based on pain ratings given by participants on the scale of 0 to 10 where, 0 represents "no pain" and 10 represents "the worst pain possible". Participants were provided with a daily diary to record information about participant-reported scores for endometriosis pain each day. Daily scores were standardized to a 28-day period for each interval (Baseline, On-drug Cycle 1 and Off-drug Cycle 1) calculated as the sum of scores in the interval divided by the number of the days in the interval multiplied by 28. A negative change from Baseline indicates improvement.

Outcome measures

Measure	Placebo n=17 Participants Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.	Telapristone Acetate 6 mg n=20 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.	Telapristone Acetate 12 mg n=23 Participants Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.
Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) SAP Baseline	67.9 score on a scale per 28-day period Standard Deviation 13.26	64.7 score on a scale per 28-day period Standard Deviation 15.29	60.6 score on a scale per 28-day period Standard Deviation 13.86
Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) SAP Change from BL to On-Drug Cycle 1	-2.52 score on a scale per 28-day period Standard Deviation 4.527	-9.43 score on a scale per 28-day period Standard Deviation 14.480	-0.53 score on a scale per 28-day period Standard Deviation 10.544
Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) SAP Change from BL to Off-Drug Cycle 1	-2.21 score on a scale per 28-day period Standard Deviation 10.125	-5.88 score on a scale per 28-day period Standard Deviation 27.822	3.04 score on a scale per 28-day period Standard Deviation 14.071
Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) EP Baseline	136.9 score on a scale per 28-day period Standard Deviation 72.48	136.2 score on a scale per 28-day period Standard Deviation 70.60	142.4 score on a scale per 28-day period Standard Deviation 70.92
Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) EP Change from BL to On-Drug Cycle 1	-42.84 score on a scale per 28-day period Standard Deviation 39.777	-52.05 score on a scale per 28-day period Standard Deviation 39.140	-25.98 score on a scale per 28-day period Standard Deviation 40.954
Change From Baseline in Participant-Reported Pain Using a Numerical Rating Scale (NRS) EP Change from BL to Off-Drug Cycle 1	-44.91 score on a scale per 28-day period Standard Deviation 43.163	-27.06 score on a scale per 28-day period Standard Deviation 46.525	-29.02 score on a scale per 28-day period Standard Deviation 45.496

Adverse Events

Placebo (Stage 2)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Telapristone Acetate 6 mg (Stage 2)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Telapristone Acetate 12 mg (Stage 2)

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo:Telapristone Acetate 12 mg (Stage 3)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Telapristone Acetate 6 mg (Stage 3)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Telapristone Acetate 12 mg (Stage 3)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo (Stage 2) n=17 participants at risk Following the Stage 1 no treatment baseline assessment period, placebo matching capsules, orally, once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an off-drug interval (ODI) in Stage 3.	Telapristone Acetate 6 mg (Stage 2) n=20 participants at risk Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 6 mg capsules, orally once daily for 18 weeks in Stage 2. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 6 mg/day separated by an ODI in Stage 3.	Telapristone Acetate 12 mg (Stage 2) n=23 participants at risk Following the Stage 1 no treatment baseline assessment period, telapristone acetate (Proellex®) 12 mg capsules, orally once daily for 18 weeks. Eligible participants had the option to receive 2 additional 16-week cycles of active treatment at 12 mg/day separated by an ODI in Stage 3.	Placebo:Telapristone Acetate 12 mg (Stage 3) n=6 participants at risk Eligible participants who received placebo in Stage 2 and opted to receive up to 2 additional 16-week cycles of telapristone acetate (Proellex®) 12 mg/day in Stage 3.	Telapristone Acetate 6 mg (Stage 3) n=5 participants at risk Eligible participants who received telapristone acetate 6 mg in Stage 2 and opted to receive up to 2 additional 16-week cycles of telapristone acetate (Proellex®) 6 mg/day in Stage 3.	Telapristone Acetate 12 mg (Stage 3) n=11 participants at risk Eligible participants who received telapristone acetate 12 mg in Stage 2 and opted to receive 2 additional 16-week cycles of telapristone acetate (Proellex®) 12 mg/day in Stage 3.
Blood and lymphatic system disorders Lymphadenitis	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Cardiac disorders Mitral valve incompetence	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Ear and labyrinth disorders Vertigo	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Gastrointestinal disorders Abdominal pain	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	8.7% 2/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Gastrointestinal disorders Constipation	11.8% 2/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	16.7% 1/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	9.1% 1/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Gastrointestinal disorders Diarrhoea	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Gastrointestinal disorders Dyspepsia	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	10.0% 2/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Gastrointestinal disorders Gastroenteritis	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	20.0% 1/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Gastrointestinal disorders Nausea	17.6% 3/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	15.0% 3/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	17.4% 4/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Gastrointestinal disorders Oesophagitis	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	20.0% 1/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Gastrointestinal disorders Toothache	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Gastrointestinal disorders Umbilical hernia	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Gastrointestinal disorders Vomiting	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
General disorders Chest pain	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
General disorders Fatigue	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
General disorders Hot flush	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	10.0% 2/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	21.7% 5/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	16.7% 1/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	20.0% 1/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
General disorders Pyrexia	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Immune system disorders Hypersensitivity	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	20.0% 1/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Immune system disorders Seasonal allergy	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	16.7% 1/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Infections and infestations Bronchitis	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	8.7% 2/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Infections and infestations Conjunctivitis infective	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Infections and infestations Cystitis	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Infections and infestations Endocarditis	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Infections and infestations Folliculitis	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Infections and infestations Influenza	17.6% 3/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Infections and infestations Pharyngitis	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Infections and infestations Pharyngitis streptococcal	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Infections and infestations Upper respiratory tract infection	11.8% 2/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Infections and infestations Urinary tract infection	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	10.0% 2/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	8.7% 2/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	18.2% 2/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Infections and infestations Vulvitis	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	16.7% 1/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Infections and infestations Vulvovaginal mycotic infection	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Investigations Alanine aminotransferase increased	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	8.7% 2/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Investigations Aspartate aminotransferase increased	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	16.7% 1/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	20.0% 1/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	9.1% 1/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Investigations Smear cervix abnormal	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Metabolism and nutrition disorders Dehydration	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Musculoskeletal and connective tissue disorders Back pain	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	8.7% 2/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	16.7% 1/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	20.0% 1/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	9.1% 1/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Musculoskeletal and connective tissue disorders Muscle strain	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	16.7% 1/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Nervous system disorders Dizziness	23.5% 4/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	25.0% 5/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	21.7% 5/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	18.2% 2/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Nervous system disorders Headache	11.8% 2/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	25.0% 5/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	21.7% 5/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Nervous system disorders Migraine	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	16.7% 1/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	9.1% 1/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Psychiatric disorders Anxiety	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	20.0% 1/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Psychiatric disorders Depression	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	8.7% 2/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Psychiatric disorders Insomnia	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Psychiatric disorders Intentional self-injury	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Psychiatric disorders Mood swings	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	8.7% 2/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Renal and urinary disorders Asymptomatic bacteriuria	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Renal and urinary disorders Nephrolithiasis	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Renal and urinary disorders Urinary tract infection	11.8% 2/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Reproductive system and breast disorders Adnexa uteri pain	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Reproductive system and breast disorders Amenorrhoea	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Reproductive system and breast disorders Breast pain	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Reproductive system and breast disorders Breast tenderness	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	8.7% 2/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Reproductive system and breast disorders Endometrial hypertrophy	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	45.0% 9/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	8.7% 2/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	50.0% 3/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	40.0% 2/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	9.1% 1/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Reproductive system and breast disorders Menorrhagia	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Reproductive system and breast disorders Nipple pain	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Reproductive system and breast disorders Ovarian cyst	23.5% 4/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	10.0% 2/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	8.7% 2/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Reproductive system and breast disorders Ovarian disorder	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Reproductive system and breast disorders Pelvic pain	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	8.7% 2/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	16.7% 1/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Reproductive system and breast disorders Vaginal infection	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Reproductive system and breast disorders Vaginal odour	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	10.0% 2/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Respiratory, thoracic and mediastinal disorders Sinusitis	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Skin and subcutaneous tissue disorders Acne	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	4.3% 1/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Skin and subcutaneous tissue disorders Rash	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Surgical and medical procedures Hysterectomy	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	20.0% 1/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Surgical and medical procedures Wisdom teeth removal	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Vascular disorders Hypertension	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Vascular disorders Hypotension	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Vascular disorders Lower gastrointestinal haemorrhage	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Vascular disorders Rectal haemorrhage	0.00% 0/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	5.0% 1/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.
Vascular disorders Uterine haemorrhage	5.9% 1/17 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/20 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/23 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/6 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/5 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.	0.00% 0/11 • From first dose of study drug through 30 days after the last dose of study drug (approximately 67 weeks) AEs were reported according to the actual treatment received in Stage 2 and Stage 3.

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER