Trial Outcomes & Findings for Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections of BMN165 by Adults With PKU (NCT NCT01889862)

NCT ID: NCT01889862

Last Updated: 2021-05-21

Results Overview

Blood phe concentration in subjects previously exposed to BMN165 who were administered BMN165 20 or 40 mg/day compared with those who were administered a matching placebo.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 215 participants
• Primary outcome timeframe: At Part 2 baseline and change from baseline at Part 2 week 8
• Results posted on: 2021-05-21

Participant Flow

This was a multicenter study, conducted in 29 study centers of United States.

A total of 51 out of 215 subjects entered Part 4 directly from 165-301, as they did not receive target dose of 20 or 40 mg/day in 165-301.

Participant milestones

Measure	BMN165 20mg/Day BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Placebo 20mg/Day Matching placebo 20mg/day subcutaneous injection administered using vial and syringe in Part 2.	BMN165 40mg/Day BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Placebo 40mg/Day Matching placebo 40mg/day subcutaneous injection administered using vial and syringe in Part 2.	BMN165 Up to 60mg/day BMN165 subcutaneous injection administered using a prefilled syringe in Part 4.
Part 1 (Up to 13 Weeks) STARTED	86	0	78	0	0
Part 1 (Up to 13 Weeks) COMPLETED	74	0	78	0	0
Part 1 (Up to 13 Weeks) NOT COMPLETED	12	0	0	0	0
Part 2 (8 Weeks) STARTED	34	15	32	14	0
Part 2 (8 Weeks) Per Amendment #2 of the Protocol	29	14	29	14	0
Part 2 (8 Weeks) COMPLETED	34	15	31	14	0
Part 2 (8 Weeks) NOT COMPLETED	0	0	1	0	0
Part 3A/B (6 Week) STARTED	48	0	41	0	0
Part 3A/B (6 Week) Per Amendment #2 of the Protocol	34	0	26	0	0
Part 3A/B (6 Week) COMPLETED	48	0	41	0	0
Part 3A/B (6 Week) NOT COMPLETED	0	0	0	0	0
Part 4 (Up to 274 Weeks) STARTED	0	0	0	0	202
Part 4 (Up to 274 Weeks) COMPLETED	0	0	0	0	172
Part 4 (Up to 274 Weeks) NOT COMPLETED	0	0	0	0	30

Reasons for withdrawal

Measure	BMN165 20mg/Day BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Placebo 20mg/Day Matching placebo 20mg/day subcutaneous injection administered using vial and syringe in Part 2.	BMN165 40mg/Day BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Placebo 40mg/Day Matching placebo 40mg/day subcutaneous injection administered using vial and syringe in Part 2.	BMN165 Up to 60mg/day BMN165 subcutaneous injection administered using a prefilled syringe in Part 4.
Part 1 (Up to 13 Weeks) Adverse Event	4	0	0	0	0
Part 1 (Up to 13 Weeks) Withdrawal by Subject	2	0	0	0	0
Part 1 (Up to 13 Weeks) Lost to Follow-up	4	0	0	0	0
Part 1 (Up to 13 Weeks) Physician Decision	2	0	0	0	0
Part 2 (8 Weeks) Withdrawal by Subject	0	0	1	0	0
Part 4 (Up to 274 Weeks) Adverse Event	0	0	0	0	5
Part 4 (Up to 274 Weeks) Subject withdrew consent	0	0	0	0	14
Part 4 (Up to 274 Weeks) Lost to Follow-up	0	0	0	0	4
Part 4 (Up to 274 Weeks) Physician Decision	0	0	0	0	5
Part 4 (Up to 274 Weeks) Protocol deviations	0	0	0	0	2

Baseline Characteristics

Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections of BMN165 by Adults With PKU

Baseline characteristics by cohort

Measure	All Subjects n=215 Participants BMN165 20mg/Day: BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B. Placebo 20mg/Day: Matching placebo 20mg/day subcutaneous injection administered using vial and syringe in Part 2. BMN165 40mg/Day: BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B. Placebo 40mg/Day: Matching placebo 40mg/day subcutaneous injection administered using vial and syringe in Part 2. BMN165: Up to 60mg/day BMN165 subcutaneous injection administered using a prefilled syringe in Part 4.
Age, Continuous	29.22 yrs STANDARD_DEVIATION 8.74 • n=5 Participants
Age, Customized 16 - <18 years	11 Participants n=5 Participants
Age, Customized 18 - <66 years	204 Participants n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants
Sex: Female, Male Male	110 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants
Race/Ethnicity, Customized White	211 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Part 2 baseline and change from baseline at Part 2 week 8

Population: Modified Intent-to-Treat (mITT) population consists of all subjects who reached the randomized dose of 20mg/day or 40mg/day and were randomized into Part 2 with a mean blood Phe reduction of ≥20% (using the last two consecutive blood Phe assessments of Part 1) from the baseline of 165-301 (or the Phase 2 study in which they initiated BMN165).

Blood phe concentration in subjects previously exposed to BMN165 who were administered BMN165 20 or 40 mg/day compared with those who were administered a matching placebo.

Outcome measures

Measure	BMN165 20mg/Day n=29 Participants BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Placebo 20mg/Day n=14 Participants Matching placebo 20mg/day subcutaneous injection administered using vial and syringe in Part 2.	BMN165 40mg/Day n=29 Participants BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Placebo 40mg/Day n=14 Participants Matching placebo 40mg/day subcutaneous injection administered using vial and syringe in Part 2.	BMN165 All Dose - Part 4 Up to 60mg/day BMN165 subcutaneous injection administered using a prefilled syringe in Part 4.
Change From Baseline in the Blood Plasma Phenylalanine (Phe) Concentration at Part 2 Part 2 Baseline	596.8 µmol/L Standard Deviation 582.75	563.9 µmol/L Standard Deviation 504.62	410.9 µmol/L Standard Deviation 439.95	508.2 µmol/L Standard Deviation 363.68	—
Change From Baseline in the Blood Plasma Phenylalanine (Phe) Concentration at Part 2 Change from Baseline Part 2 Week 8	-65.9 µmol/L Standard Deviation 192.02	996.4 µmol/L Standard Deviation 555.00	114.1 µmol/L Standard Deviation 332.40	599.0 µmol/L Standard Deviation 507.40	—

SECONDARY outcome

Timeframe: At Part 2 baseline and change from baseline at Part 2 week 8

Population: mITT population

Attention deficit hyperactivity disorder rating scale IV (ADHD RS-IV) is investigator-rated, 9-item, inattention subscale score ranges from 0 to 27, with higher scores indicative of a greater degree of impairment and a baseline score >9 indicative of a presence of symptoms.

Outcome measures

Measure	BMN165 20mg/Day n=29 Participants BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Placebo 20mg/Day n=14 Participants Matching placebo 20mg/day subcutaneous injection administered using vial and syringe in Part 2.	BMN165 40mg/Day n=29 Participants BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Placebo 40mg/Day n=14 Participants Matching placebo 40mg/day subcutaneous injection administered using vial and syringe in Part 2.	BMN165 All Dose - Part 4 Up to 60mg/day BMN165 subcutaneous injection administered using a prefilled syringe in Part 4.
Change From Baseline in the Cognitive and Mood Symptoms Measured by ADHD Rating Scale (RS)-IV Inattention Subscale at Part 2 Change from Baseline Part 2 Week 8	1.1 Units on a scale Standard Deviation 3.96	1.2 Units on a scale Standard Deviation 3.00	0.5 Units on a scale Standard Deviation 5.36	-0.4 Units on a scale Standard Deviation 3.44	—
Change From Baseline in the Cognitive and Mood Symptoms Measured by ADHD Rating Scale (RS)-IV Inattention Subscale at Part 2 Baseline	5.9 Units on a scale Standard Deviation 4.70	5.0 Units on a scale Standard Deviation 4.26	6.0 Units on a scale Standard Deviation 6.45	2.9 Units on a scale Standard Deviation 3.68	—

SECONDARY outcome

Timeframe: At Part 4 week 57, 105, 161, 209 and 249

Population: All Subjects Entered 165-302 Part 4 Data

The long term effect of multiple dose levels of BMN165 on blood phe concentration in subjects who are administered BMN165 using pre-filled syringes.

Outcome measures

Measure	BMN165 20mg/Day n=61 Participants BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Placebo 20mg/Day n=131 Participants Matching placebo 20mg/day subcutaneous injection administered using vial and syringe in Part 2.	BMN165 40mg/Day n=184 Participants BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Placebo 40mg/Day n=62 Participants Matching placebo 40mg/day subcutaneous injection administered using vial and syringe in Part 2.	BMN165 All Dose - Part 4 n=202 Participants Up to 60mg/day BMN165 subcutaneous injection administered using a prefilled syringe in Part 4.
Change From Baseline in the Blood Plasma Phenylalanine (Phe) Concentration at Part 4 Change from Baseline to Part 4 Week 57	-1004.9 µmol/L Standard Deviation 541.19	-984.0 µmol/L Standard Deviation 531.33	-810.2 µmol/L Standard Deviation 595.24	-662.3 µmol/L Standard Deviation 465.61	-839.5 µmol/L Standard Deviation 562.74
Change From Baseline in the Blood Plasma Phenylalanine (Phe) Concentration at Part 4 Change from Baseline to Part 4 Week 105	-1015.3 µmol/L Standard Deviation 557.00	-1109.2 µmol/L Standard Deviation 474.25	-858.5 µmol/L Standard Deviation 593.73	-641.0 µmol/L Standard Deviation 568.67	-890.8 µmol/L Standard Deviation 578.38
Change From Baseline in the Blood Plasma Phenylalanine (Phe) Concentration at Part 4 Change from Baseline to Part 4 Week 161	-1006.5 µmol/L Standard Deviation 514.76	-1111.9 µmol/L Standard Deviation 519.40	-662.8 µmol/L Standard Deviation 433.80	-808.6 µmol/L Standard Deviation 558.22	-882.0 µmol/L Standard Deviation 528.61
Change From Baseline in the Blood Plasma Phenylalanine (Phe) Concentration at Part 4 Change from Baseline to Part 4 Week 209	-897.3 µmol/L Standard Deviation 494.41	-1020.4 µmol/L Standard Deviation 495.79	-541.6 µmol/L Standard Deviation 245.83	-961.7 µmol/L Standard Deviation 339.92	-842.3 µmol/L Standard Deviation 418.37
Change From Baseline in the Blood Plasma Phenylalanine (Phe) Concentration at Part 4 Change from Baseline to Part 4 Week 249	-1059.5 µmol/L Standard Deviation 160.51	—	—	-1314.0 µmol/L Standard Deviation NA Number of subjects participated in week 249 visit is one.	-1144.3 µmol/L Standard Deviation 185.67

SECONDARY outcome

Timeframe: At Part 2 baseline and change from baseline at Part 2 week 8

Population: mITT population

Phenylketonuria (PKU) Total Mood Disturbance (TMD) Profile of Mood States (POMS)

PKU POMS TMD is self-rated, each item in the tool is rated using a five-point Likert scale: 0 (not at all), 1 (a little), 2 (moderately), 3 (quite a bit), and 4 (extremely).

Outcome measures

Measure	BMN165 20mg/Day n=29 Participants BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Placebo 20mg/Day n=14 Participants Matching placebo 20mg/day subcutaneous injection administered using vial and syringe in Part 2.	BMN165 40mg/Day n=29 Participants BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Placebo 40mg/Day n=14 Participants Matching placebo 40mg/day subcutaneous injection administered using vial and syringe in Part 2.	BMN165 All Dose - Part 4 Up to 60mg/day BMN165 subcutaneous injection administered using a prefilled syringe in Part 4.
Change From Baseline in the Cognitive and Mood Symptoms Measured by PKU POMS TMD at Part 2 Change from Baseline Part 2 Week 8	4.8 Units on a scale Standard Deviation 12.63	4.3 Units on a scale Standard Deviation 11.96	-2.0 Units on a scale Standard Deviation 10.25	0.0 Units on a scale Standard Deviation 14.08	—
Change From Baseline in the Cognitive and Mood Symptoms Measured by PKU POMS TMD at Part 2 Baseline	7.1 Units on a scale Standard Deviation 14.18	8.6 Units on a scale Standard Deviation 10.84	8.9 Units on a scale Standard Deviation 12.28	5.0 Units on a scale Standard Deviation 8.56	—

SECONDARY outcome

Timeframe: At Part 2 baseline and change from baseline at Part 2 week 8

Population: mITT population

PKU POMS confusion mood domain (referred to as the confusion subscale) is self-rated, each item in the tool is rated using a five-point Likert scale: 0 (not at all), 1 (a little), 2 (moderately), 3 (quite a bit), and 4 (extremely).

Outcome measures

Measure	BMN165 20mg/Day n=29 Participants BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Placebo 20mg/Day n=14 Participants Matching placebo 20mg/day subcutaneous injection administered using vial and syringe in Part 2.	BMN165 40mg/Day n=29 Participants BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Placebo 40mg/Day n=14 Participants Matching placebo 40mg/day subcutaneous injection administered using vial and syringe in Part 2.	BMN165 All Dose - Part 4 Up to 60mg/day BMN165 subcutaneous injection administered using a prefilled syringe in Part 4.
Change From Baseline in the Cognitive and Mood Symptoms Measured by PKU POMS Confusion Subscale at Part 2 Baseline	2.0 Units on a scale Standard Deviation 2.09	2.1 Units on a scale Standard Deviation 1.49	2.4 Units on a scale Standard Deviation 2.02	1.2 Units on a scale Standard Deviation 1.53	—
Change From Baseline in the Cognitive and Mood Symptoms Measured by PKU POMS Confusion Subscale at Part 2 Change from Baseline Part 2 Week 8	0.8 Units on a scale Standard Deviation 2.79	1.4 Units on a scale Standard Deviation 2.47	-0.3 Units on a scale Standard Deviation 1.84	0.5 Units on a scale Standard Deviation 2.22	—

SECONDARY outcome

Timeframe: At Part 2 baseline and change from baseline at Part 2 week 8

Population: mITT population

Full-length POMS TMD is self-rated, each item in the tool is rated using a five-point Likert scale: 0 (not at all), 1 (a little), 2 (moderately), 3 (quite a bit), and 4 (extremely).

Outcome measures

Measure	BMN165 20mg/Day n=29 Participants BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Placebo 20mg/Day n=14 Participants Matching placebo 20mg/day subcutaneous injection administered using vial and syringe in Part 2.	BMN165 40mg/Day n=29 Participants BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 1, 2 and 3A. BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Placebo 40mg/Day n=14 Participants Matching placebo 40mg/day subcutaneous injection administered using vial and syringe in Part 2.	BMN165 All Dose - Part 4 Up to 60mg/day BMN165 subcutaneous injection administered using a prefilled syringe in Part 4.
Change From Baseline in the Cognitive and Mood Symptoms Measured by POMS TMD at Part 2 Baseline	16.2 Units on a scale Standard Deviation 35.63	18.1 Units on a scale Standard Deviation 28.26	24.3 Units on a scale Standard Deviation 35.38	13.3 Units on a scale Standard Deviation 21.63	—
Change From Baseline in the Cognitive and Mood Symptoms Measured by POMS TMD at Part 2 Change from Baseline Part 2 Week 8	13.1 Units on a scale Standard Deviation 30.73	7.3 Units on a scale Standard Deviation 26.23	-3.2 Units on a scale Standard Deviation 26.63	-1.7 Units on a scale Standard Deviation 29.34	—

Adverse Events

Part 1 - 20 mg/Day

Serious events: 6 serious events

Other events: 70 other events

Deaths: 0 deaths

Part 1 - 40 mg/Day

Serious events: 2 serious events

Other events: 59 other events

Deaths: 0 deaths

Part 2 - 20 mg/Day Active

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Part 2 - 40 mg/Day Active

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

Part 2 - 20 mg/Day Placebo

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Part 2 - 40 mg/Day Placebo

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Part 3 - Stay on Active 20 mg/Day

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Part 3 - Stay on Active 40 mg/Day

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Part 3 - Switch From Placebo to Active 20 mg/Day

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 3 - Switch From Placebo to Active 40 mg/Day

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part 4 - < 20 mg/Day

Serious events: 7 serious events

Other events: 62 other events

Deaths: 0 deaths

Part 4 - 20 to < 40 mg/Day

Serious events: 6 serious events

Other events: 105 other events

Deaths: 0 deaths

Part 4 - 40 to < 60 mg/Day

Serious events: 16 serious events

Other events: 178 other events

Deaths: 0 deaths

Part 4 - >= 60 mg/Day

Serious events: 5 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1 - 20 mg/Day n=86 participants at risk BMN165 20mg/day subcutaneous injection administered using vial and syringe.	Part 1 - 40 mg/Day n=78 participants at risk BMN165 40mg/day subcutaneous injection administered using vial and syringe.	Part 2 - 20 mg/Day Active n=34 participants at risk BMN165 20mg/day subcutaneous injection administered using vial and syringe.	Part 2 - 40 mg/Day Active n=32 participants at risk BMN165 40mg/day subcutaneous injection administered using vial and syringe.	Part 2 - 20 mg/Day Placebo n=15 participants at risk Matching placebo 20mg/day subcutaneous injection administered using vial and syringe.	Part 2 - 40 mg/Day Placebo n=14 participants at risk Matching placebo 40mg/day subcutaneous injection administered using vial and syringe.	Part 3 - Stay on Active 20 mg/Day n=23 participants at risk BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 3A. BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Part 3 - Stay on Active 40 mg/Day n=18 participants at risk BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 3A. BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Part 3 - Switch From Placebo to Active 20 mg/Day n=11 participants at risk BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 3A. BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Part 3 - Switch From Placebo to Active 40 mg/Day n=8 participants at risk BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 3A. BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Part 4 - < 20 mg/Day n=67 participants at risk BMN165 \<20mg/day subcutaneous injection administered using a prefilled syringe.	Part 4 - 20 to < 40 mg/Day n=152 participants at risk BMN165 20 to \<40mg/day subcutaneous injection administered using a prefilled syringe.	Part 4 - 40 to < 60 mg/Day n=186 participants at risk BMN165 40 to \<60mg/day subcutaneous injection administered using a prefilled syringe.	Part 4 - >= 60 mg/Day n=89 participants at risk BMN165 \>=60mg/day subcutaneous injection administered using a prefilled syringe.
Gastrointestinal disorders Haemorrhoidal Haemorrhage	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Gastrointestinal disorders Haemorrhoids	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Gastrointestinal disorders Pancreatitis	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Investigations Blood pressure increased	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Chest Pain	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 2/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Non-cardiac Chest Pain	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 2/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Blood and lymphatic system disorders Lymphoid Tissue Hyperplasia	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Appendix Adenoma	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Xanthogranuloma	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Skin and subcutaneous tissue disorders Angioedema	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Skin and subcutaneous tissue disorders Skin Exfoliation	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Cardiac disorders Tachycardia	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Injury, poisoning and procedural complications Road Traffic Accident	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.0% 2/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Nervous system disorders Loss of consciousness	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Nervous system disorders Migraine	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Nervous system disorders Presyncope	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Pregnancy, puerperium and perinatal conditions Abortion missed	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Pregnancy, puerperium and perinatal conditions Hyperemesis gravidarum	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Reproductive system and breast disorders Endometriosis	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Immune system disorders Hypersensitivity	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 2/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Investigations Blood creatine phosphokinase increased	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Psychiatric disorders Agitation	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Psychiatric disorders Depression	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Immune system disorders Anaphylactic Reaction	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 4/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Immune system disorders Anaphylactoid Reaction	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Psychiatric disorders Anxiety	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Psychiatric disorders Brief Psychotic Disorder with Marked Stressors	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Psychiatric disorders Parasomnia	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Cellulitis	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Appendicitis	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Gastrointestinal disorders Epiploic Appendagitis	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Diverticulitis	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Pneumonia	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Soft Tissue Infection	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.

Other adverse events

Measure	Part 1 - 20 mg/Day n=86 participants at risk BMN165 20mg/day subcutaneous injection administered using vial and syringe.	Part 1 - 40 mg/Day n=78 participants at risk BMN165 40mg/day subcutaneous injection administered using vial and syringe.	Part 2 - 20 mg/Day Active n=34 participants at risk BMN165 20mg/day subcutaneous injection administered using vial and syringe.	Part 2 - 40 mg/Day Active n=32 participants at risk BMN165 40mg/day subcutaneous injection administered using vial and syringe.	Part 2 - 20 mg/Day Placebo n=15 participants at risk Matching placebo 20mg/day subcutaneous injection administered using vial and syringe.	Part 2 - 40 mg/Day Placebo n=14 participants at risk Matching placebo 40mg/day subcutaneous injection administered using vial and syringe.	Part 3 - Stay on Active 20 mg/Day n=23 participants at risk BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 3A. BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Part 3 - Stay on Active 40 mg/Day n=18 participants at risk BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 3A. BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Part 3 - Switch From Placebo to Active 20 mg/Day n=11 participants at risk BMN165 20mg/day subcutaneous injection administered using vial and syringe in Part 3A. BMN165 20mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Part 3 - Switch From Placebo to Active 40 mg/Day n=8 participants at risk BMN165 40mg/day subcutaneous injection administered using vial and syringe in Part 3A. BMN165 40mg/day subcutaneous injection administered using a prefilled syringe in Part 3B.	Part 4 - < 20 mg/Day n=67 participants at risk BMN165 \<20mg/day subcutaneous injection administered using a prefilled syringe.	Part 4 - 20 to < 40 mg/Day n=152 participants at risk BMN165 20 to \<40mg/day subcutaneous injection administered using a prefilled syringe.	Part 4 - 40 to < 60 mg/Day n=186 participants at risk BMN165 40 to \<60mg/day subcutaneous injection administered using a prefilled syringe.	Part 4 - >= 60 mg/Day n=89 participants at risk BMN165 \>=60mg/day subcutaneous injection administered using a prefilled syringe.
Respiratory, thoracic and mediastinal disorders Cough	7.0% 6/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	14.3% 2/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.0% 6/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.2% 20/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	15.6% 29/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.2% 10/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Injection site swelling	5.8% 5/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 2/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.0% 4/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 9/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	10.2% 19/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.4% 3/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Injection site erythema	4.7% 4/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.4% 5/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 2/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.2% 2/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 3/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.0% 3/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	10.2% 19/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.9% 7/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Pyrexia	2.3% 2/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.0% 4/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 4/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	10.2% 19/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 6/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Peripheral swelling	2.3% 2/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 3/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 4/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	8.1% 15/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 2/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Pain	2.3% 2/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.1% 2/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.5% 5/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 2/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.4% 10/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 5/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Nasopharyngitis	8.1% 7/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	14.1% 11/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.8% 4/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	8.7% 2/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	22.4% 15/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	17.8% 27/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	31.7% 59/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	21.3% 19/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Upper respiratory tract infection	9.3% 8/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.4% 5/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	20.0% 3/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	14.3% 2/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.0% 3/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.1% 2/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	20.9% 14/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	19.1% 29/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	27.4% 51/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.2% 10/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Sinusitis	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.4% 9/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	8.6% 13/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.8% 22/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.4% 11/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Influenza	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 3/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.3% 5/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	8.1% 15/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.0% 8/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Bronchitis	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 3/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 9/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.0% 13/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.4% 3/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Gastroenteritis viral	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.5% 5/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.6% 7/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 11/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.9% 7/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Urinary tract infection	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.8% 3/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 2/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 3/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.3% 5/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.0% 13/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.4% 3/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Pharyngitis streptococcal	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 3/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.4% 10/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 4/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Ear infection	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.8% 3/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 3/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 4/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.2% 6/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.4% 3/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Viral infection	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.0% 2/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.0% 3/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.4% 10/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Gastroenteritis	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.0% 4/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 2/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.2% 6/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 2/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Conjunctivitis	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 4/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.2% 6/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Fungal infection	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.0% 3/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 2/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.4% 3/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Injection site reaction	15.1% 13/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.0% 7/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.8% 4/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.0% 3/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.0% 6/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.2% 14/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	24.7% 46/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.4% 11/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Injection site bruising	10.5% 9/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.0% 7/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 2/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.3% 2/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	8.7% 2/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.5% 5/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.2% 14/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	22.0% 41/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.5% 12/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Injection site pruritus	7.0% 6/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.8% 3/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 3/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 9/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.9% 24/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.2% 10/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Fatigue	9.3% 8/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.8% 3/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.8% 4/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.4% 3/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	20.0% 3/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	21.7% 5/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	22.2% 4/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	14.9% 10/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.3% 8/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.5% 14/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.2% 10/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Injection site induration	2.3% 2/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.0% 4/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.2% 14/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.9% 24/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 6/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Injection site pain	3.5% 3/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 3/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.6% 10/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.8% 22/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	10.1% 9/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Injection site mass	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.8% 3/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 2/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.5% 12/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Non-cardiac chest pain	2.3% 2/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 4/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.4% 10/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Injection site haemorrhage	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.2% 2/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 3/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.3% 5/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.7% 5/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 5/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Musculoskeletal and connective tissue disorders Arthralgia	10.5% 9/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	16.7% 13/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	20.6% 7/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.2% 2/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	14.3% 2/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.0% 3/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	27.3% 3/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	25.0% 2/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	23.9% 16/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	21.7% 33/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	34.4% 64/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	24.7% 22/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Musculoskeletal and connective tissue disorders Back pain	4.7% 4/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	14.9% 10/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.2% 14/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	17.7% 33/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.9% 7/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Musculoskeletal and connective tissue disorders Pain in extremity	5.8% 5/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.1% 4/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.4% 9/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.2% 14/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.9% 24/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.2% 10/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	3.5% 3/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.8% 3/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.0% 4/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.9% 6/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	8.6% 16/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.4% 3/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Musculoskeletal and connective tissue disorders Myalgia	2.3% 2/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.8% 3/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.2% 2/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.0% 4/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.3% 5/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	8.1% 15/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 2/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.5% 5/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.5% 12/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 5/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Musculoskeletal and connective tissue disorders Muscle spasms	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 3/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.0% 3/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 8/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 5/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Nervous system disorders Headache	18.6% 16/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	15.4% 12/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	17.6% 6/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.2% 2/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	20.0% 3/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	28.6% 4/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	8.7% 2/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	16.7% 3/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	29.9% 20/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	19.1% 29/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	31.7% 59/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	27.0% 24/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Nervous system disorders Dizziness	2.3% 2/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.0% 7/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.2% 2/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	14.9% 10/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.9% 6/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.3% 21/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.4% 11/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Nervous system disorders Migraine	3.5% 3/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.2% 2/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.0% 6/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.3% 8/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.7% 18/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	10.1% 9/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Nervous system disorders Disturbance in attention	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.8% 4/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.3% 2/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.0% 3/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.7% 5/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.4% 3/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Nervous system disorders Lethargy	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.3% 2/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 8/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Nervous system disorders Memory impairment	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	8.8% 3/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.0% 2/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 4/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Nervous system disorders Tremor	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.0% 4/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 4/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 2/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Skin and subcutaneous tissue disorders Rash	2.3% 2/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.7% 6/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 2/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.4% 3/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	8.7% 2/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.1% 2/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	10.4% 7/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.3% 8/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	18.3% 34/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	15.7% 14/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Skin and subcutaneous tissue disorders Pruritus	2.3% 2/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.0% 7/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 4/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.0% 6/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	8.6% 13/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	17.7% 33/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	15.7% 14/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Skin and subcutaneous tissue disorders Urticaria	4.7% 4/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 2/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.0% 4/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.9% 12/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	15.1% 28/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.5% 12/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Skin and subcutaneous tissue disorders Alopecia	2.3% 2/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.1% 4/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 2/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.3% 2/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.5% 5/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.9% 12/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.5% 12/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 6/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Skin and subcutaneous tissue disorders Erythema	3.5% 3/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.5% 5/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.9% 6/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.8% 9/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 4/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.0% 2/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 2/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 8/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 4/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Gastrointestinal disorders Vomiting	4.7% 4/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.9% 8/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.8% 18/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	18.3% 34/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	14.6% 13/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Gastrointestinal disorders Nausea	5.8% 5/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.4% 5/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.8% 4/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	16.7% 3/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	14.9% 10/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.2% 11/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	15.1% 28/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	18.0% 16/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Gastrointestinal disorders Diarrhoea	4.7% 4/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.4% 5/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 2/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.2% 2/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.9% 8/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.9% 15/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.4% 25/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	10.1% 9/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Gastrointestinal disorders Abdominal pain upper	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	10.4% 7/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.3% 5/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 17/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 4/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Gastrointestinal disorders Dyspepsia	3.5% 3/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.8% 3/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 3/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.6% 10/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.4% 10/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 5/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Gastrointestinal disorders Abdominal pain	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 2/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.0% 4/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.6% 7/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.4% 10/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 6/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Gastrointestinal disorders Toothache	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.0% 4/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.9% 6/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.5% 12/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 5/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.2% 2/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 3/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.9% 6/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 8/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	10.1% 9/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Gastrointestinal disorders Constipation	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.0% 2/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.0% 3/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.4% 10/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 6/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Gastrointestinal disorders Abdominal discomfort	2.3% 2/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.0% 3/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 11/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 2/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.7% 4/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.7% 6/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.0% 6/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.2% 14/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	17.2% 32/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.0% 8/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.7% 4/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	20.0% 3/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.4% 9/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.9% 12/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	10.8% 20/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.0% 8/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Respiratory, thoracic and mediastinal disorders Sinus congestion	3.5% 3/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 2/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	10.4% 7/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.3% 5/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.5% 12/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 4/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 2/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.8% 7/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.4% 3/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Injury, poisoning and procedural complications Contusion	3.5% 3/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.8% 3/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.3% 2/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	18.2% 2/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.4% 9/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 9/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.8% 22/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 5/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.0% 3/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.5% 12/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 4/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.0% 2/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.3% 5/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.8% 7/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 5/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Injury, poisoning and procedural complications Muscle strain	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.0% 2/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 2/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 8/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 2/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Investigations Amino acid level decreased	3.5% 3/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.4% 9/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	8.6% 13/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	19.9% 37/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	14.6% 13/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Investigations Blood creatine phosphokinase increased	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.3% 2/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.2% 6/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Investigations Complement factor C3 decreased	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 2/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.7% 5/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Psychiatric disorders Anxiety	2.3% 2/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.8% 4/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.4% 3/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	14.3% 2/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	16.4% 11/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.6% 10/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.4% 23/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 6/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Psychiatric disorders Depression	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.2% 2/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.3% 2/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.4% 9/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.2% 11/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.0% 13/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.4% 3/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Psychiatric disorders Insomnia	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.4% 3/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.0% 6/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.6% 7/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 17/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 2/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Psychiatric disorders Irritability	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.2% 2/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	13.3% 2/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.0% 2/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 2/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Immune system disorders Seasonal allergy	2.3% 2/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.2% 2/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	11.9% 8/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.9% 6/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	10.2% 19/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.4% 3/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Immune system disorders Hypersensitivity	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 2/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.0% 3/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.4% 10/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 2/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Reproductive system and breast disorders Dysmenorrhoea	5.8% 5/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	8.8% 3/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	8.7% 2/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.0% 2/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.6% 4/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.8% 9/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.4% 3/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.4% 5/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	14.3% 2/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.3% 8/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.7% 18/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.4% 3/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Ear and labyrinth disorders Ear pain	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.0% 3/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 4/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 2/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Psychiatric disorders Agitation	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.4% 3/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Chest discomfort	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 2/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 2/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Psychiatric disorders Depressive symptom	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.9% 2/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 2/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Nervous system disorders Dyspraxia	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Psychiatric disorders Mood altered	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	14.3% 2/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 2/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Nervous system disorders Sciatica	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Eye disorders Blepharospasm	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Investigations Blood bilirubin increased	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Psychiatric disorders Distractibility	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Psychiatric disorders Emotional disorder	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Feeling abnormal	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 2/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 2/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Fungal skin infection	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Nervous system disorders Hyperreflexia	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.0% 2/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 4/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 2/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Inflammation	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Renal and urinary disorders Ketonuria	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 2/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Laryngitis	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.6% 3/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Nervous system disorders Paraesthesia	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 2/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.7% 5/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 2/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Injury, poisoning and procedural complications Post-traumatic pain	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Renal and urinary disorders Proteinuria	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 2/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 2/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.4% 3/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.0% 2/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 2/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Injury, poisoning and procedural complications Skin abrasion	2.3% 2/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 2/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Nervous system disorders Somnolence	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Ear and labyrinth disorders Tinnitus	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Renal and urinary disorders Urine odour abnormal	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Ear and labyrinth disorders Vertigo	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 3/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.6% 3/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Investigations Weight decreased	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	7.1% 1/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Investigations Weight increased	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	6.7% 1/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Investigations Blood cortisol decreased	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 1/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.3% 1/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	4.5% 3/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 2/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.2% 6/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Chest pain	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.1% 1/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.2% 6/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Investigations Complement factor decreased	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Injury, poisoning and procedural complications Injury	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Labyrinthitis	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	3.0% 2/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
General disorders Malaise	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Skin and subcutaneous tissue disorders Papule	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.3% 2/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 4/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Nervous system disorders Presyncope	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.5% 1/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.6% 3/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.9% 1/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Psychiatric disorders Stress	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	12.5% 1/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	2.2% 2/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Infections and infestations Vaginal infection	1.2% 1/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	9.1% 1/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.54% 1/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 1/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 2/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 1/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.
Gastrointestinal disorders Abdominal distension	0.00% 0/86 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/78 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/34 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/32 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/15 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/14 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/23 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/18 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/11 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/8 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.00% 0/67 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	0.66% 1/152 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	1.1% 2/186 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.	5.6% 5/89 • Up to 301 weeks Safety Analyses consists of the population for safety analyses of all subjects who enrolled into the study and all subjects who enrolled into each study part for analysis by study part.

Additional Information

Debra Lounsbury/Sr Principle Scientist, Clinical Sciences

BioMarin Pharmaceutical Inc

Phone: 415-506-6348

Email: Dlounsbury@bmrn.com

Results disclosure agreements

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

Restriction type: GT60