Trial Outcomes & Findings for Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD (NCT NCT02766608)

Last Updated: 2019-09-24

Results Overview

Change from baseline in morning pre-dose trough FEV1 (Forced expiratory volume in 1 second) at Week 24 (BFF MDI versus FF MDI)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2389 participants

Primary outcome timeframe

at Week 24

Results posted on

2019-09-24

Participant Flow

This study randomized subjects at 244 study centers in 7 countries, from June 2016 and November 2017. The study period was scheduled to take up to approximately 30 weeks for each individual subject from the time of screening through the follow-up period.

Subjects were randomized in a 3:3:3:1:1 ratio to BFF 320/9.6, BFF 160/9.6, FF 9.6, BD 320, and Symbicort.

Participant milestones

Participant milestones
Measure	BFF MDI 320/9.6 μg Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 μg Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 μg Symbicort Turbuhaler 400/12 μg
Overall Study STARTED	655	637	644	206	219
Overall Study COMPLETED	576	567	554	169	190
Overall Study NOT COMPLETED	79	70	90	37	29

Reasons for withdrawal

Reasons for withdrawal
Measure	BFF MDI 320/9.6 μg Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 μg Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 μg Symbicort Turbuhaler 400/12 μg
Overall Study Adverse Event	27	22	17	13	12
Overall Study Withdrawal by Subject	21	20	24	13	10
Overall Study Lack of Efficacy	16	15	32	8	2
Overall Study Lost to Follow-up	6	3	5	2	2
Overall Study Physician Decision	3	2	3	1	2
Overall Study Protocol disc criteria	3	3	4	0	0
Overall Study Protocol Violation	0	4	4	0	1
Overall Study Administrative Reasons	3	1	1	0	0

Baseline Characteristics

mITT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BFF MDI 320/9.6 μg n=664 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=649 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=648 Participants Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 μg n=209 Participants Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 μg n=219 Participants Symbicort Turbuhaler 400/12 μg	Total n=2389 Participants Total of all reporting groups
Age, Continuous	64.2 Years STANDARD_DEVIATION 7.7 • n=655 Participants • mITT	64.3 Years STANDARD_DEVIATION 7.6 • n=637 Participants • mITT	64.1 Years STANDARD_DEVIATION 8.0 • n=644 Participants • mITT	64.2 Years STANDARD_DEVIATION 7.4 • n=206 Participants • mITT	65.3 Years STANDARD_DEVIATION 7.0 • n=219 Participants • mITT	64.3 Years STANDARD_DEVIATION 7.7 • n=2361 Participants • mITT
Sex: Female, Male Values listed are mITT population · Female	253 Participants n=655 Participants • mITT	260 Participants n=637 Participants • mITT	261 Participants n=644 Participants • mITT	81 Participants n=206 Participants • mITT	78 Participants n=219 Participants • mITT	933 Participants n=2361 Participants • mITT
Sex: Female, Male Values listed are mITT population · Male	402 Participants n=655 Participants • mITT	377 Participants n=637 Participants • mITT	383 Participants n=644 Participants • mITT	125 Participants n=206 Participants • mITT	141 Participants n=219 Participants • mITT	1428 Participants n=2361 Participants • mITT
Ethnicity (NIH/OMB) Values listed are mITT population · Hispanic or Latino	16 Participants n=655 Participants • mITT	18 Participants n=637 Participants • mITT	21 Participants n=644 Participants • mITT	8 Participants n=206 Participants • mITT	6 Participants n=219 Participants • mITT	69 Participants n=2361 Participants • mITT
Ethnicity (NIH/OMB) Values listed are mITT population · Not Hispanic or Latino	637 Participants n=655 Participants • mITT	616 Participants n=637 Participants • mITT	623 Participants n=644 Participants • mITT	198 Participants n=206 Participants • mITT	212 Participants n=219 Participants • mITT	2286 Participants n=2361 Participants • mITT
Ethnicity (NIH/OMB) Values listed are mITT population · Unknown or Not Reported	2 Participants n=655 Participants • mITT	3 Participants n=637 Participants • mITT	0 Participants n=644 Participants • mITT	0 Participants n=206 Participants • mITT	1 Participants n=219 Participants • mITT	6 Participants n=2361 Participants • mITT
Race (NIH/OMB) Values listed are mITT population · American Indian or Alaska Native	2 Participants n=655 Participants • mITT	2 Participants n=637 Participants • mITT	2 Participants n=644 Participants • mITT	0 Participants n=206 Participants • mITT	0 Participants n=219 Participants • mITT	6 Participants n=2361 Participants • mITT
Race (NIH/OMB) Values listed are mITT population · Asian	1 Participants n=655 Participants • mITT	1 Participants n=637 Participants • mITT	0 Participants n=644 Participants • mITT	0 Participants n=206 Participants • mITT	1 Participants n=219 Participants • mITT	3 Participants n=2361 Participants • mITT
Race (NIH/OMB) Values listed are mITT population · Native Hawaiian or Other Pacific Islander	0 Participants n=655 Participants • mITT	0 Participants n=637 Participants • mITT	0 Participants n=644 Participants • mITT	0 Participants n=206 Participants • mITT	0 Participants n=219 Participants • mITT	0 Participants n=2361 Participants • mITT
Race (NIH/OMB) Values listed are mITT population · Black or African American	19 Participants n=655 Participants • mITT	15 Participants n=637 Participants • mITT	20 Participants n=644 Participants • mITT	9 Participants n=206 Participants • mITT	8 Participants n=219 Participants • mITT	71 Participants n=2361 Participants • mITT
Race (NIH/OMB) Values listed are mITT population · White	633 Participants n=655 Participants • mITT	619 Participants n=637 Participants • mITT	622 Participants n=644 Participants • mITT	197 Participants n=206 Participants • mITT	210 Participants n=219 Participants • mITT	2281 Participants n=2361 Participants • mITT
Race (NIH/OMB) Values listed are mITT population · More than one race	0 Participants n=655 Participants • mITT	0 Participants n=637 Participants • mITT	0 Participants n=644 Participants • mITT	0 Participants n=206 Participants • mITT	0 Participants n=219 Participants • mITT	0 Participants n=2361 Participants • mITT
Race (NIH/OMB) Values listed are mITT population · Unknown or Not Reported	0 Participants n=655 Participants • mITT	0 Participants n=637 Participants • mITT	0 Participants n=644 Participants • mITT	0 Participants n=206 Participants • mITT	0 Participants n=219 Participants • mITT	0 Participants n=2361 Participants • mITT

PRIMARY outcome

Timeframe: at Week 24

Population: mITT

Change from baseline in morning pre-dose trough FEV1 (Forced expiratory volume in 1 second) at Week 24 (BFF MDI versus FF MDI)

Outcome measures

Outcome measures
Measure	BFF MDI 320/9.6 μg n=571 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=564 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=550 Participants Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 ug Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 ug Symbicort Turbuhaler 400/12 ug
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI)	0.036 Liter Interval 0.019 to 0.053	0.017 Liter Interval 0.0 to 0.034	-0.003 Liter Interval -0.02 to 0.015	—	—

PRIMARY outcome

Timeframe: at Week 24

Population: mITT

Changes from baseline in FEV1 AUC0-4 were normalized by taking the area under the curve value and dividing by the length of time under consideration (usually 4 hours). This normalization represents a weighted average of the change from baseline in FEV1 over the 4-hour period.

Outcome measures

Outcome measures
Measure	BFF MDI 320/9.6 μg n=571 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=565 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=549 Participants Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 ug n=168 Participants Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 ug n=189 Participants Symbicort Turbuhaler 400/12 ug
Change From Baseline in FEV1 AUC0-4 (BFF MDI vs BD MDI)	0.194 Liter Interval 0.177 to 0.212	0.179 Liter Interval 0.161 to 0.197	0.161 Liter Interval 0.143 to 0.179	0.022 Liter Interval -0.011 to 0.054	0.187 Liter Interval 0.157 to 0.218

SECONDARY outcome

Timeframe: over 24 Weeks (timepoints of 4, 12 & 20 weeks)

Population: mITT

Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation (BFF MDI vs FF MDI).

Outcome measures

Outcome measures
Measure	BFF MDI 320/9.6 μg n=655 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=637 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=644 Participants Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 ug n=206 Participants Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 ug n=219 Participants Symbicort Turbuhaler 400/12 ug
Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI). Percentage of Subjects to Exacerbate at 4 Weeks	3.2 Percentage of Participants Interval 2.1 to 4.9	3.3 Percentage of Participants Interval 2.2 to 5.1	5.5 Percentage of Participants Interval 4.0 to 7.6	7.0 Percentage of Participants Interval 4.2 to 11.5	1.8 Percentage of Participants Interval 0.7 to 4.8
Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI). Percentage of Subjects to Exacerbate at 12 Weeks	9.8 Percentage of Participants Interval 7.7 to 12.4	9.9 Percentage of Participants Interval 7.8 to 12.5	15.0 Percentage of Participants Interval 12.4 to 18.1	14.9 Percentage of Participants Interval 10.6 to 20.7	8.6 Percentage of Participants Interval 5.5 to 13.3
Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI). Percentage of Subjects to Exacerbate at 20 Weeks	14.4 Percentage of Participants Interval 11.9 to 17.4	18.5 Percentage of Participants Interval 15.6 to 21.8	20.5 Percentage of Participants Interval 17.5 to 23.9	17.7 Percentage of Participants Interval 13.0 to 23.9	13.1 Percentage of Participants Interval 9.2 to 18.6

SECONDARY outcome

Timeframe: at Week 24

Population: mITT

The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI, FF MDI, BD MDI, \& Symbicort TBH on health-related quality of life as compared to placebo in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.

Outcome measures

Outcome measures
Measure	BFF MDI 320/9.6 μg n=649 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=635 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=640 Participants Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 ug n=204 Participants Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 ug n=217 Participants Symbicort Turbuhaler 400/12 ug
Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in SGRQ at Week 24	48.12 Percentage of Subjects	47.22 Percentage of Subjects	41.59 Percentage of Subjects	43.62 Percentage of Subjects	53.78 Percentage of Subjects

SECONDARY outcome

Timeframe: at Week 24

Population: mITT

Change from baseline in morning pre-dose trough FEV1(Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)

Outcome measures

Outcome measures
Measure	BFF MDI 320/9.6 μg n=571 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=564 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=550 Participants Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 ug n=168 Participants Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 ug n=189 Participants Symbicort Turbuhaler 400/12 ug
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI vs BD MDI)	0.036 Liter Interval 0.019 to 0.053	0.017 Liter Interval 0.0 to 0.034	-0.003 Liter Interval -0.02 to 0.015	-0.028 Liter Interval -0.06 to 0.003	0.039 Liter Interval 0.009 to 0.069

SECONDARY outcome

Timeframe: at Week 24

Population: mITT

Peak change from baseline in FEV1 (Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)

Outcome measures

Outcome measures
Measure	BFF MDI 320/9.6 μg n=571 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=565 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=549 Participants Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 ug n=168 Participants Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 ug n=189 Participants Symbicort Turbuhaler 400/12 ug
Peak Change From Baseline in FEV1 at Week 24 (BFF MDI vs BD MDI)	0.272 Liter Interval 0.254 to 0.291	0.258 Liter Interval 0.239 to 0.276	0.243 Liter Interval 0.224 to 0.261	0.116 Liter Interval 0.082 to 0.15	0.267 Liter Interval 0.253 to 0.299

SECONDARY outcome

Timeframe: over 24 Weeks

Population: mITT

Change from baseline in average daily rescue Ventolin HFA use over 24 weeks (BFF MDI vs BD MDI)

Outcome measures

Outcome measures
Measure	BFF MDI 320/9.6 μg n=654 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=636 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=641 Participants Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 ug n=206 Participants Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 ug n=218 Participants Symbicort Turbuhaler 400/12 ug
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks (BFF MDI vs BD MDI)	-1.3 Puffs per day Interval -1.5 to -1.1	-1.3 Puffs per day Interval -1.4 to -1.1	-1.1 Puffs per day Interval -1.2 to -0.9	-0.6 Puffs per day Interval -0.9 to -0.3	-1.2 Puffs per day Interval -1.5 to -0.9

SECONDARY outcome

Timeframe: Day 1 - 5 Minutes

Population: mITT

Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.

Outcome measures

Outcome measures
Measure	BFF MDI 320/9.6 μg n=535 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=536 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=534 Participants Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 ug n=171 Participants Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 ug n=173 Participants Symbicort Turbuhaler 400/12 ug
FEV1 on Day 1, 5 Minutes, Time to Onset of Action Determination	0.157 Liter Interval 0.148 to 0.166	0.151 Liter Interval 0.142 to 0.161	0.160 Liter Interval 0.15 to 0.169	0.025 Liter Interval 0.009 to 0.041	0.131 Liter Interval 0.115 to 0.148

SECONDARY outcome

Timeframe: Day 1 - 15 Minutes

Population: mITT

Outcome measures

Outcome measures
Measure	BFF MDI 320/9.6 μg n=624 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=615 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=612 Participants Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 ug n=203 Participants Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 ug n=211 Participants Symbicort Turbuhaler 400/12 ug
FEV1 on Day 1, 15 Minutes, Time to Onset of Action Determination	0.190 Liter Interval 0.18 to 0.2	0.186 Liter Interval 0.176 to 0.196	0.201 Liter Interval 0.191 to 0.211	0.040 Liter Interval 0.022 to 0.058	0.167 Liter Interval 0.149 to 0.184

SECONDARY outcome

Timeframe: Day 1 - 30 Minutes

Population: mITT

Outcome measures

Outcome measures
Measure	BFF MDI 320/9.6 μg n=648 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=627 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=638 Participants Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 ug n=203 Participants Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 ug n=214 Participants Symbicort Turbuhaler 400/12 ug
FEV1 on Day 1, 30 Minutes, Time to Onset of Action Determination	0.207 Liter Interval 0.196 to 0.217	0.207 Liter Interval 0.196 to 0.218	0.215 Liter Interval 0.205 to 0.226	0.047 Liter Interval 0.028 to 0.066	0.190 Liter Interval 0.172 to 0.209

SECONDARY outcome

Timeframe: Day 1 - 1 Hour

Population: mITT

Outcome measures

Outcome measures
Measure	BFF MDI 320/9.6 μg n=649 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=628 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=640 Participants Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 ug n=204 Participants Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 ug n=215 Participants Symbicort Turbuhaler 400/12 ug
FEV1 on Day 1, 1 Hour, Time to Onset of Action Determination	0.225 Liter Interval 0.213 to 0.236	0.221 Liter Interval 0.21 to 0.233	0.236 Liter Interval 0.225 to 0.248	0.053 Liter Interval 0.033 to 0.073	0.211 Liter Interval 0.191 to 0.231

SECONDARY outcome

Timeframe: Day 1 - 2 Hours

Population: mITT

Outcome measures

Outcome measures
Measure	BFF MDI 320/9.6 μg n=649 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=629 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=636 Participants Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 ug n=205 Participants Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 ug n=217 Participants Symbicort Turbuhaler 400/12 ug
FEV1 on Day 1, 2 Hours, Time to Onset of Action Determination	0.253 Liter Interval 0.241 to 0.265	0.234 Liter Interval 0.222 to 0.247	0.244 Liter Interval 0.231 to 0.256	0.063 Liter Interval 0.042 to 0.085	0.221 Liter Interval 0.2 to 0.243

SECONDARY outcome

Timeframe: Day 1 - 4 Hours

Population: mITT

Outcome measures

Outcome measures
Measure	BFF MDI 320/9.6 μg n=651 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=630 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=634 Participants Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 ug n=201 Participants Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 ug n=217 Participants Symbicort Turbuhaler 400/12 ug
FEV1 on Day 1, 4 Hours, Time to Onset of Action Determination	0.230 Liter Interval 0.216 to 0.243	0.215 Liter Interval 0.202 to 0.229	0.212 Liter Interval 0.199 to 0.226	0.073 Liter Interval 0.049 to 0.097	0.209 Liter Interval 0.186 to 0.232

OTHER_PRE_SPECIFIED outcome

Timeframe: at Week 12

Population: mITT

Substudy: 12-hour PFT (Pulmonary Function Test) endpoint FEV1 (Forced Expiratory Volume) AUC0-12 (Area under the Curve 0-12). Changes from baseline in FEV1 AUC0-12 were normalized by taking the area under the curve value and dividing by the length of time under consideration. This normalization represents a weighted average of the change from baseline in FEV1 over the 12-hour period.

Outcome measures

Outcome measures
Measure	BFF MDI 320/9.6 μg n=160 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=167 Participants Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=189 Participants Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 ug n=47 Participants Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 ug Symbicort Turbuhaler 400/12 ug
Substudy: 12-hour PFT Endpoint FEV1 AUC0-12	0.135 Liter Interval 0.107 to 0.163	0.124 Liter Interval 0.097 to 0.152	0.117 Liter Interval 0.089 to 0.145	0.024 Liter Interval -0.028 to 0.075	—

Adverse Events

BFF MDI 320/9.6 μg

Serious events: 42 serious events

Other events: 240 other events

Deaths: 3 deaths

BFF MDI 160/9.6 μg

Serious events: 45 serious events

Other events: 201 other events

Deaths: 2 deaths

FF MDI 9.6 μg

Serious events: 72 serious events

Other events: 219 other events

Deaths: 2 deaths

BD MDI 320 μg

Serious events: 15 serious events

Other events: 75 other events

Deaths: 0 deaths

Symbicort TBH 400/12 μg

Serious events: 20 serious events

Other events: 57 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	BFF MDI 320/9.6 μg n=655 participants at risk Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=637 participants at risk Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=644 participants at risk Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 μg n=206 participants at risk Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 μg n=219 participants at risk Symbicort Turbuhaler 400/12 μg
Cardiac disorders Cardiac failure congestive	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.97% 2/206 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Cardiac disorders Acute myocardial infarction	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.31% 2/637 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.31% 2/644 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Gastrointestinal disorders Hiatus hernia	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Gastrointestinal disorders Inflammatory bowel disease	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Gastrointestinal disorders Inguinal hernia	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.49% 1/206 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.3% 15/655 • Number of events 16 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.6% 10/637 • Number of events 10 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	4.5% 29/644 • Number of events 35 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.97% 2/206 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	2.7% 6/219 • Number of events 6 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.31% 2/655 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.31% 2/637 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.62% 4/644 • Number of events 4 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Cardiac disorders Atrial fibrillation	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.78% 5/637 • Number of events 5 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.31% 2/644 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.49% 1/206 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Cardiac disorders Angina pectoris	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.31% 2/637 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Cardiac disorders Angina unstable	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.31% 2/637 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Cardiac disorders Atrial flutter	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.49% 1/206 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Cardiac disorders Cardiac failure	0.31% 2/655 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Cardiac disorders Cardiac failure chronic	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.31% 2/637 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Cardiac disorders Myocardial ischaemia	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.49% 1/206 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Cardiac disorders Atrioventricular block complete	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.49% 1/206 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Cardiac disorders Cardiac arrest	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Cardiac disorders Coronary artery disease	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Cardiac disorders Congestive cardiomyopathy	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Cardiac disorders Coronary artery stenosis	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.49% 1/206 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Cardiac disorders Myocardial infarction	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.49% 1/206 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Infections and infestations Pneumonia	0.61% 4/655 • Number of events 4 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.78% 5/637 • Number of events 5 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.93% 6/644 • Number of events 7 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.4% 3/219 • Number of events 3 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Infections and infestations Abdominal hernia gangrenous	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Infections and infestations Breast abscess	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Infections and infestations Cellulitis	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Infections and infestations Clostridium difficile colitis	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Infections and infestations Sepsis	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Infections and infestations Staphylococcal infection	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Infections and infestations Tooth abscess	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Nervous system disorders Ischaemic stroke	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.31% 2/644 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Nervous system disorders Cerebrovascular accident	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Nervous system disorders Transient ischaemic attack	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Nervous system disorders Carotid artery stenosis	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Nervous system disorders Embolic stroke	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.49% 1/206 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Nervous system disorders Epilepsy	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Nervous system disorders Hypoaesthesia	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Nervous system disorders Intracranial aneurysm	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Nervous system disorders Syncope	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.31% 2/644 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Gastrointestinal disorders Pancreatitis acute	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.91% 2/219 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Gastrointestinal disorders Abdominal pain	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Gastrointestinal disorders Colitis ischaemic	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Gastrointestinal disorders Diverticulum intestinal	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Gastrointestinal disorders Gastrointestinal ulcer	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Gastrointestinal disorders Pancreatitis	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Gastrointestinal disorders Strangulated umbilical hernia	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.49% 1/206 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Injury, poisoning and procedural complications Hip fracture	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Injury, poisoning and procedural complications Acetabulum fracture	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Injury, poisoning and procedural complications Dural tear	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Injury, poisoning and procedural complications Femur fracture	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Injury, poisoning and procedural complications Lower limb fracture	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Injury, poisoning and procedural complications Radius fracture	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.49% 1/206 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Injury, poisoning and procedural complications Rib fracture	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Injury, poisoning and procedural complications Thermal burn	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.49% 1/206 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer male	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.49% 1/206 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric neoplasm	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.49% 1/206 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma of the bladder	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Hepatobiliary disorders Cholecystitis	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.49% 1/206 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Hepatobiliary disorders Bile duct stone	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Hepatobiliary disorders Cholelithiasis	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Hepatobiliary disorders Cholecystitis acute	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Musculoskeletal and connective tissue disorders Tendonitis	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Vascular disorders Arteriosclerosis	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Vascular disorders Haematoma	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Vascular disorders Hypertensive emergency	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Vascular disorders Peripheral artery thrombosis	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Vascular disorders Peripheral ischaemia	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Vascular disorders Thrombophlebitis superficial	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
General disorders Chest discomfort	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
General disorders Chest pain	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
General disorders Death	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
General disorders Incarcerated hernia	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
General disorders Sudden cardiac death	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Metabolism and nutrition disorders Cachexia	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Metabolism and nutrition disorders Diabetes with hyperosmolarity	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Metabolism and nutrition disorders Gout	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Renal and urinary disorders Acute kidney injury	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Renal and urinary disorders Chronic kidney disease	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Renal and urinary disorders Hypertonic bladder	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Renal and urinary disorders Renal tubular necrosis	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Eye disorders Cataract	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Product Issues Device battery issue	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Psychiatric disorders Mental status changes	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Reproductive system and breast disorders Prostatic haemorrhage	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Injury, poisoning and procedural complications Skull fractured base	0.00% 0/655 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/644 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Renal and urinary disorders Renal cyst	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/637 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/644 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).

Other adverse events

Other adverse events
Measure	BFF MDI 320/9.6 μg n=655 participants at risk Budesonide Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	BFF MDI 160/9.6 μg n=637 participants at risk Budesonide Formoterol Fumarate Metered Dose Inhalation 160/9.6 μg	FF MDI 9.6 μg n=644 participants at risk Formoterol Fumarate Metered Dose Inhalation 9.6 μg	BD MDI 320 μg n=206 participants at risk Budesonide Metered Dose Inhalation 320 μg	Symbicort TBH 400/12 μg n=219 participants at risk Symbicort Turbuhaler 400/12 μg
Infections and infestations Nasopharyngitis	6.1% 40/655 • Number of events 46 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	6.3% 40/637 • Number of events 44 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	6.7% 43/644 • Number of events 46 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	8.3% 17/206 • Number of events 18 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	6.4% 14/219 • Number of events 18 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Infections and infestations Upper respiratory tract infection	3.8% 25/655 • Number of events 27 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	3.3% 21/637 • Number of events 24 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	3.1% 20/644 • Number of events 20 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	2.4% 5/206 • Number of events 7 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.4% 3/219 • Number of events 3 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Infections and infestations Chronic obstructive pulmonary disease	2.4% 16/655 • Number of events 17 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.6% 10/637 • Number of events 10 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	4.7% 30/644 • Number of events 36 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.97% 2/206 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	2.7% 6/219 • Number of events 6 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Vascular disorders Hypertension	2.1% 14/655 • Number of events 14 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	3.5% 22/637 • Number of events 22 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	2.3% 15/644 • Number of events 15 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	2.4% 5/206 • Number of events 5 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.8% 4/219 • Number of events 5 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Musculoskeletal and connective tissue disorders Back pain	2.7% 18/655 • Number of events 21 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	2.0% 13/637 • Number of events 14 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	2.8% 18/644 • Number of events 19 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.5% 3/206 • Number of events 3 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.91% 2/219 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Nervous system disorders Headache	2.9% 19/655 • Number of events 27 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.3% 8/637 • Number of events 10 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	2.3% 15/644 • Number of events 15 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.5% 3/206 • Number of events 4 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 3 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Respiratory, thoracic and mediastinal disorders Cough	1.1% 7/655 • Number of events 8 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	2.4% 15/637 • Number of events 15 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	2.3% 15/644 • Number of events 15 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	3.4% 7/206 • Number of events 7 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/219 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Infections and infestations Oral candidiasis	2.6% 17/655 • Number of events 18 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	2.2% 14/637 • Number of events 15 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.78% 5/644 • Number of events 6 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.5% 3/206 • Number of events 3 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.4% 3/219 • Number of events 3 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.8% 12/655 • Number of events 12 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.7% 11/637 • Number of events 11 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.4% 9/644 • Number of events 9 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	3.4% 7/206 • Number of events 7 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.4% 3/219 • Number of events 3 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Infections and infestations Bronchitis	2.4% 16/655 • Number of events 17 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.1% 7/637 • Number of events 8 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.6% 10/644 • Number of events 10 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.9% 4/206 • Number of events 4 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.91% 2/219 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Infections and infestations Sinusitis	1.5% 10/655 • Number of events 12 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.4% 9/637 • Number of events 10 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.9% 12/644 • Number of events 13 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.97% 2/206 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	2.3% 5/219 • Number of events 5 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Gastrointestinal disorders Diarrhoea	1.4% 9/655 • Number of events 9 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.4% 9/637 • Number of events 9 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.4% 9/644 • Number of events 9 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	2.4% 5/206 • Number of events 6 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	1.4% 3/219 • Number of events 3 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Respiratory, thoracic and mediastinal disorders Dysphonia	2.4% 16/655 • Number of events 16 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	2.0% 13/637 • Number of events 13 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.47% 3/644 • Number of events 3 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.97% 2/206 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Musculoskeletal and connective tissue disorders Muscle spasms	2.1% 14/655 • Number of events 15 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.94% 6/637 • Number of events 6 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.93% 6/644 • Number of events 7 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.00% 0/206 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	3.7% 8/219 • Number of events 8 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
Psychiatric disorders Anxiety	0.92% 6/655 • Number of events 6 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.31% 2/637 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.62% 4/644 • Number of events 4 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	2.4% 5/206 • Number of events 5 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).
General disorders Fatigue	0.15% 1/655 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.16% 1/637 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.78% 5/644 • Number of events 5 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	2.4% 5/206 • Number of events 5 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).	0.46% 1/219 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug Serious Adverse Events were collected from the time the subject signed informed consent throughout the treatment period and up to approximately 30 weeks, which includes screening and follow up (14 days after last dose of study drug).

Additional Information

Paul M. Dorinsky, MD

Pearl Therapeutics, a Member of the AstraZeneca Group

Phone: 650-305-2600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.
Publication restrictions are in place

Restriction type: OTHER