Trial Outcomes & Findings for A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions (NCT NCT02395042)

NCT ID: NCT02395042

Last Updated: 2018-10-05

Results Overview

The participant recorded their daily bladder pain score over the previous 24-hour period on a 7-day pain assessment tool as measured by an NRS on an 11-point scale where 0=no pain to 10=worst pain imaginable. The daily pain scores over the 7-day period were averaged. A negative change from Baseline indicates improvement. An analysis of covariance (ANCOVA) model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors was used for analysis.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 59 participants
• Primary outcome timeframe: Baseline (Day -7 to Day 0) to Week 4
• Results posted on: 2018-10-05

Participant Flow

Participant milestones

Measure	LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.	LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.	LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2) Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.
Treatment 1 Period STARTED	12	31	16
Treatment 1 Period COMPLETED	9	25	14
Treatment 1 Period NOT COMPLETED	3	6	2
Treatment 2 Period STARTED	10	24	13
Treatment 2 Period COMPLETED	9	23	13
Treatment 2 Period NOT COMPLETED	1	1	0

Reasons for withdrawal

Measure	LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.	LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.	LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2) Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.
Treatment 1 Period Adverse Event	1	3	1
Treatment 1 Period Lack of Efficacy	1	1	0
Treatment 1 Period Lost to Follow-up	1	0	0
Treatment 1 Period Other Miscellaneous Reasons	0	2	1
Treatment 2 Period Lack of Efficacy	1	1	0

Baseline Characteristics

Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with available baseline data.

Baseline characteristics by cohort

Measure	LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) n=12 Participants Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.	LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) n=31 Participants Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.	LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2) n=16 Participants Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.	Total n=59 Participants Total of all reporting groups
Age, Continuous	53.58 years STANDARD_DEVIATION 12.09 • n=12 Participants	57.65 years STANDARD_DEVIATION 12.76 • n=31 Participants	57.31 years STANDARD_DEVIATION 14.25 • n=16 Participants	56.73 years STANDARD_DEVIATION 12.93 • n=59 Participants
Sex: Female, Male Female	12 Participants n=12 Participants	31 Participants n=31 Participants	16 Participants n=16 Participants	59 Participants n=59 Participants
Sex: Female, Male Male	0 Participants n=12 Participants	0 Participants n=31 Participants	0 Participants n=16 Participants	0 Participants n=59 Participants
Race/Ethnicity, Customized Caucasian	8 Participants n=12 Participants	29 Participants n=31 Participants	16 Participants n=16 Participants	53 Participants n=59 Participants
Race/Ethnicity, Customized Black	3 Participants n=12 Participants	1 Participants n=31 Participants	0 Participants n=16 Participants	4 Participants n=59 Participants
Race/Ethnicity, Customized Asian	0 Participants n=12 Participants	1 Participants n=31 Participants	0 Participants n=16 Participants	1 Participants n=59 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=12 Participants	0 Participants n=31 Participants	0 Participants n=16 Participants	1 Participants n=59 Participants
Daily Average Bladder Pain Numeric Rating Scale (NRS)	6.0 score on a scale n=11 Participants • Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with available baseline data.	5.5 score on a scale n=28 Participants • Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with available baseline data.	5.6 score on a scale n=14 Participants • Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with available baseline data.	5.7 score on a scale n=53 Participants • Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with available baseline data.

PRIMARY outcome

Timeframe: Baseline (Day -7 to Day 0) to Week 4

Population: Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with data available for analysis.

The participant recorded their daily bladder pain score over the previous 24-hour period on a 7-day pain assessment tool as measured by an NRS on an 11-point scale where 0=no pain to 10=worst pain imaginable. The daily pain scores over the 7-day period were averaged. A negative change from Baseline indicates improvement. An analysis of covariance (ANCOVA) model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors was used for analysis.

Outcome measures

Measure	LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) n=9 Participants Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.	LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) n=26 Participants Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.	LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2) n=10 Participants Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.
Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS)	-1.6 score on a scale Interval -2.68 to -0.45	-2.7 score on a scale Interval -3.36 to -2.06	-2.5 score on a scale Interval -3.53 to -1.44

SECONDARY outcome

Timeframe: Baseline (Day 0) to Week 4

Population: Modified Intent-to-Treat population, all participants who were randomized and received Treatment 1, with data available for analysis.

During each cystoscopy, the investigator counted the number of lesions visible while performing the bladder scan. A negative change from Baseline indicates improvement (less lesions). An ANCOVA model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or > 5) as factors was used for analysis.

Outcome measures

Measure	LiRIS Placebo, LiRIS Placebo (Tx 1)/LiRIS® (Tx 2) n=8 Participants Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14.	LiRIS®, LiRIS® (Tx 1)/LiRIS® (Tx 2) n=18 Participants Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14.	LiRIS Placebo, LiRIS® (Tx 1)/ LiRIS® (Tx 2) n=12 Participants Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14.
Change From Baseline in the Number of Hunner's Lesions	0.8 Hunner's lesions Interval -0.04 to 1.7	-0.6 Hunner's lesions Interval -1.21 to -0.05	-0.2 Hunner's lesions Interval -0.87 to 0.5

SECONDARY outcome

Timeframe: Baseline (Day 1) to Week 4

Population: Data for the planned composite Hunner's Lesions score were supposed to be generated based on digital images by a software algorithm, but the system never worked and no data were generated.

A standardized video capture protocol for bladder mapping was followed to assess any changes in the number, the size and the severity, of lesions during the study as a result of treatment. A negative change from Baseline indicates improvement.

Outcome measures

Outcome data not reported

Adverse Events

LiRIS Placebo, LiRIS Placebo (Tx 1)

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

LiRIS®, LiRIS® (Tx 1)

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

LiRIS Placebo, LiRIS® (Tx 1)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

LiRIS Placebo, LiRIS Placebo/LiRIS® (Tx 2)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

LiRIS®, LiRIS® /LiRIS® (Tx 2)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

LiRIS Placebo, LiRIS /LiRIS® (Tx 2)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	LiRIS Placebo, LiRIS Placebo (Tx 1) n=12 participants at risk Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Adverse events (AEs) reported in Tx 1.	LiRIS®, LiRIS® (Tx 1) n=31 participants at risk Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. AEs reported in Tx 1.	LiRIS Placebo, LiRIS® (Tx 1) n=16 participants at risk Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. AEs reported in Tx 1.	LiRIS Placebo, LiRIS Placebo/LiRIS® (Tx 2) n=10 participants at risk Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14. AEs reported in Tx 2.	LiRIS®, LiRIS® /LiRIS® (Tx 2) n=24 participants at risk Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14. AEs reported in Tx 2.	LiRIS Placebo, LiRIS /LiRIS® (Tx 2) n=13 participants at risk Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14. AEs reported in Tx 2.
Infections and infestations Urosepsis	8.3% 1/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.

Other adverse events

Measure	LiRIS Placebo, LiRIS Placebo (Tx 1) n=12 participants at risk Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Adverse events (AEs) reported in Tx 1.	LiRIS®, LiRIS® (Tx 1) n=31 participants at risk Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. AEs reported in Tx 1.	LiRIS Placebo, LiRIS® (Tx 1) n=16 participants at risk Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. AEs reported in Tx 1.	LiRIS Placebo, LiRIS Placebo/LiRIS® (Tx 2) n=10 participants at risk Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 10 and then removed and a second matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and removed on Day 14. AEs reported in Tx 2.	LiRIS®, LiRIS® /LiRIS® (Tx 2) n=24 participants at risk Treatment 1 Period: LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 then removed and a second LiRIS® 400 mg inserted into the bladder on Day 14 and removed on Day 28. Treatment 2 Period: optional LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 0 and then removed on Day 14. AEs reported in Tx 2.	LiRIS Placebo, LiRIS /LiRIS® (Tx 2) n=13 participants at risk Treatment 1 Period: Matching placebo device to the LiRIS inserted into the bladder by cystoscopy on Day 0 and then removed and LiRIS® (continuous release of lidocaine) 400 mg inserted into the bladder by cystoscopy on Day 14 then removed on Day 28. Treatment 2 Period: optional LiRIS® 400 mg inserted into the bladder by cystoscopy on Day 0 then removed on Day 14. AEs reported in Tx 2.
Gastrointestinal disorders Constipation	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	3.2% 1/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Gastrointestinal disorders Diarrhoea	8.3% 1/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	3.2% 1/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Gastrointestinal disorders Nausea	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	3.2% 1/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Gastrointestinal disorders Vomiting	8.3% 1/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Gastrointestinal disorders Abdominal pain upper	8.3% 1/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Gastrointestinal disorders Dry mouth	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
General disorders Medical device pain	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.5% 2/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
General disorders Suprapubic pain	8.3% 1/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.5% 2/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
General disorders Fatigue	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	3.2% 1/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
General disorders Medical device discomfort	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.5% 2/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
General disorders Thirst	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Infections and infestations Urinary tract infection	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	16.1% 5/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	12.5% 2/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	7.7% 1/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Infections and infestations Genital herpes	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	3.2% 1/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Infections and infestations Sinusitis	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.5% 2/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Infections and infestations Herpes virus infection	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Infections and infestations Nasopharyngitis	8.3% 1/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Infections and infestations Urosepsis	8.3% 1/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	3.2% 1/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Nervous system disorders Dysgeusia	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Nervous system disorders Somnolence	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Psychiatric disorders Anxiety	8.3% 1/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Psychiatric disorders Depression	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Renal and urinary disorders Dysuria	41.7% 5/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	19.4% 6/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	18.8% 3/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Renal and urinary disorders Bladder pain	8.3% 1/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	9.7% 3/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	18.8% 3/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	10.0% 1/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	4.2% 1/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Renal and urinary disorders Haematuria	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	12.9% 4/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	12.5% 2/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Renal and urinary disorders Bladder discomfort	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	12.9% 4/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Renal and urinary disorders Bladder spasm	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	3.2% 1/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Renal and urinary disorders Leukocyturia	8.3% 1/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Renal and urinary disorders Urethral pain	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	12.5% 2/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	10.0% 1/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	4.2% 1/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Renal and urinary disorders Micturition urgency	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Renal and urinary disorders Nephrolithiasis	8.3% 1/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Renal and urinary disorders Urge incontinence	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	6.2% 1/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Renal and urinary disorders Urinary retention	8.3% 1/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Gastrointestinal disorders Dyspepsia	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	7.7% 1/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Infections and infestations Genital infection fungal	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	7.7% 1/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Infections and infestations Tooth abscess	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	10.0% 1/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Investigations Liver function test increased	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	7.7% 1/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.
Nervous system disorders Headache	0.00% 0/12 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/31 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/16 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	10.0% 1/10 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/24 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.	0.00% 0/13 • Treatment 1 Period Up to Week 20 and Treatment 2 Period Up to 52 days Due to study design the Non-serious Adverse Event (AE) tables are reported separately for Treatment 1 Period and Treatment 2 Period. A result of 0 in an arm means that there were no participants in that arm at a threshold of \>=5% for the preferred term.

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