Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos) (NCT NCT02465567)

NCT ID: NCT02465567

Last Updated: 2021-02-02

Results Overview

Adjusted Rate of Moderate or Severe Exacerbations

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 8588 participants
• Primary outcome timeframe: 52-week treatment period
• Results posted on: 2021-02-02

Participant Flow

This study was conducted in 26 countries between July 2015 and July 2019.

Subjects who successfully complete the Screening Period will then be randomized in a 1:1:1:1 scheme to BGF MDI 320/14.4/9.6 μg BID, BGF MDI 160/14.4/9.6 μg BID, BFF MDI 320/9.6 μg BID, or GFF MDI 14.4/9.6 μg BID, respectively.

Participant milestones

Measure	BGF MDI 320/14.4/9.6 μg Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg	BGF MDI 160/14.4/9.6 μg Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg	GFF MDI 14.4/9.6 μg Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg	BFF MDI 320/9.6 μg Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Overall Study STARTED	2157	2137	2143	2151
Overall Study COMPLETED	1708	1713	1580	1643
Overall Study NOT COMPLETED	449	424	563	508

Reasons for withdrawal

Measure	BGF MDI 320/14.4/9.6 μg Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg	BGF MDI 160/14.4/9.6 μg Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg	GFF MDI 14.4/9.6 μg Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg	BFF MDI 320/9.6 μg Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Overall Study Adverse Event	118	113	147	138
Overall Study Lack of Efficacy	103	102	171	135
Overall Study Withdrawal by Subject	104	94	123	130
Overall Study Physician Decision	23	33	38	28
Overall Study Major Protocol Deviation	24	26	22	25
Overall Study Lost to Follow-up	25	21	19	15
Overall Study Protocol Specified Criteria	20	10	9	12
Overall Study Administrative Reasons	12	9	11	5
Overall Study Randomized but not treated	1	5	4	5
Overall Study enrolled in >1 studies	18	11	19	15
Overall Study missing PI Signature	1	0	0	0

Baseline Characteristics

Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)

Baseline characteristics by cohort

Measure	BGF MDI 320/14.4/9.6 μg n=2137 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg	BGF MDI 160/14.4/9.6 μg n=2121 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg	GFF MDI 14.4/9.6 μg n=2120 Participants Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg	BFF MDI 320/9.6 μg n=2131 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg	Total n=8509 Participants Total of all reporting groups
Age, Continuous	64.6 Years STANDARD_DEVIATION 7.6 • n=5 Participants	64.6 Years STANDARD_DEVIATION 7.6 • n=7 Participants	64.8 Years STANDARD_DEVIATION 7.6 • n=5 Participants	64.6 Years STANDARD_DEVIATION 7.6 • n=4 Participants	64.7 Years STANDARD_DEVIATION 7.6 • n=21 Participants
Sex: Female, Male Female	877 Participants n=5 Participants	823 Participants n=7 Participants	876 Participants n=5 Participants	852 Participants n=4 Participants	3428 Participants n=21 Participants
Sex: Female, Male Male	1260 Participants n=5 Participants	1298 Participants n=7 Participants	1244 Participants n=5 Participants	1279 Participants n=4 Participants	5081 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	400 Participants n=5 Participants	393 Participants n=7 Participants	426 Participants n=5 Participants	401 Participants n=4 Participants	1620 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1690 Participants n=5 Participants	1680 Participants n=7 Participants	1649 Participants n=5 Participants	1683 Participants n=4 Participants	6702 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	47 Participants n=5 Participants	48 Participants n=7 Participants	45 Participants n=5 Participants	47 Participants n=4 Participants	187 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	33 Participants n=5 Participants	40 Participants n=7 Participants	30 Participants n=5 Participants	39 Participants n=4 Participants	142 Participants n=21 Participants
Race (NIH/OMB) Asian	162 Participants n=5 Participants	166 Participants n=7 Participants	157 Participants n=5 Participants	166 Participants n=4 Participants	651 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Black or African American	78 Participants n=5 Participants	88 Participants n=7 Participants	75 Participants n=5 Participants	64 Participants n=4 Participants	305 Participants n=21 Participants
Race (NIH/OMB) White	1819 Participants n=5 Participants	1783 Participants n=7 Participants	1808 Participants n=5 Participants	1816 Participants n=4 Participants	7226 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	43 Participants n=5 Participants	44 Participants n=7 Participants	50 Participants n=5 Participants	46 Participants n=4 Participants	183 Participants n=21 Participants

PRIMARY outcome

Timeframe: 52-week treatment period

Population: mITT Population

Adjusted Rate of Moderate or Severe Exacerbations

Outcome measures

Measure	BGF MDI 320/14.4/9.6 μg n=2137 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg	BGF MDI 160/14.4/9.6 μg n=2121 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg	GFF MDI 14.4/9.6 μg n=2120 Participants Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg	BFF MDI 320/9.6 μg n=2131 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Adjusted Rate of Moderate or Severe Exacerbations	1.08 Moderate or Severe Exacerbations Standard Error 0.04	1.07 Moderate or Severe Exacerbations Standard Error 0.04	1.42 Moderate or Severe Exacerbations Standard Error 0.05	1.24 Moderate or Severe Exacerbations Standard Error 0.04

SECONDARY outcome

Timeframe: 52 Weeks

Population: mITT Population

Time to first moderate or severe COPD exacerbation (proportion with event reported as median time was not reached, statistical analyses are based upon time to event)

Outcome measures

Measure	BGF MDI 320/14.4/9.6 μg n=2137 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg	BGF MDI 160/14.4/9.6 μg n=2121 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg	GFF MDI 14.4/9.6 μg n=2120 Participants Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg	BFF MDI 320/9.6 μg n=2131 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Time to First Moderate or Severe COPD Exacerbation	1026 Participants	1013 Participants	1056 Participants	1085 Participants

SECONDARY outcome

Timeframe: 24 Weeks

Population: mITT Population

Change from baseline in average daily rescue Ventolin HFA use over 24 weeks

Outcome measures

Measure	BGF MDI 320/14.4/9.6 μg n=1425 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg	BGF MDI 160/14.4/9.6 μg n=1389 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg	GFF MDI 14.4/9.6 μg n=1387 Participants Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg	BFF MDI 320/9.6 μg n=1426 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks	-1.2 Puffs Interval -1.3 to -1.1	-1.0 Puffs Interval -1.2 to -0.9	-0.7 Puffs Interval -0.8 to -0.5	-0.8 Puffs Interval -0.9 to -0.7

SECONDARY outcome

Timeframe: at Week 24

Population: mITT Population

Percentage of subjects achieving a minimal clinically important difference (MCID) of 4 units or more in SGRQ (St. George's Respiratory Questionnaire) total score at Week 24

Outcome measures

Measure	BGF MDI 320/14.4/9.6 μg n=2119 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg	BGF MDI 160/14.4/9.6 μg n=2102 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg	GFF MDI 14.4/9.6 μg n=2096 Participants Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg	BFF MDI 320/9.6 μg n=2122 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score	1068 Participants	1024 Participants	893 Participants	949 Participants

SECONDARY outcome

Timeframe: 52 Weeks

Population: ITT Population

Subject Deaths (all cause)

Outcome measures

Measure	BGF MDI 320/14.4/9.6 μg n=2137 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg	BGF MDI 160/14.4/9.6 μg n=2121 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg	GFF MDI 14.4/9.6 μg n=2120 Participants Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg	BFF MDI 320/9.6 μg n=2131 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Time to Death (All Cause)	28 Participants	39 Participants	49 Participants	34 Participants

SECONDARY outcome

Timeframe: 52 Weeks

Population: mITT Population

Rate of severe COPD exacerbations

Outcome measures

Measure	BGF MDI 320/14.4/9.6 μg n=2137 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg	BGF MDI 160/14.4/9.6 μg n=2121 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg	GFF MDI 14.4/9.6 μg n=2120 Participants Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg	BFF MDI 320/9.6 μg n=2131 Participants Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Rate of Severe COPD Exacerbations	0.13 Severe Exacerbations Standard Error 0.01	0.14 Severe Exacerbations Standard Error 0.01	0.15 Severe Exacerbations Standard Error 0.01	0.16 Severe Exacerbations Standard Error 0.01

Adverse Events

BGF MDI 320/14.4/9.6 μg

Serious events: 426 serious events

Other events: 337 other events

Deaths: 27 deaths

BGF MDI 160/14.4/9.6 μg

Serious events: 445 serious events

Other events: 361 other events

Deaths: 42 deaths

GFF MDI 14.4/9.6 μg

Serious events: 433 serious events

Other events: 292 other events

Deaths: 47 deaths

BFF MDI 320/9.6 μg

Serious events: 440 serious events

Other events: 336 other events

Deaths: 35 deaths

Serious adverse events

Measure	BGF MDI 320/14.4/9.6 μg n=2144 participants at risk Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg	BGF MDI 160/14.4/9.6 μg n=2124 participants at risk Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg	GFF MDI 14.4/9.6 μg n=2125 participants at risk Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg	BFF MDI 320/9.6 μg n=2136 participants at risk Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
General disorders Fatigue	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
General disorders Pain	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Retroperitoneal haemorrhage	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Toothache	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Varices oesophageal	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Vomiting	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
General disorders Death	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2124 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.33% 7/2125 • Number of events 7 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
General disorders Chest pain	0.14% 3/2144 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2124 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
General disorders Multiple organ dysfunction syndrome	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
General disorders Sudden death	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
General disorders Non-cardiac chest pain	0.19% 4/2144 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2136 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
General disorders Drug withdrawal syndrome	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
General disorders Oedema peripheral	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
General disorders Asthenia	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
General disorders Capsular contracture associated with breast implant	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
General disorders Soft tissue inflamation	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
General disorders Sudden cardiac death	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
General disorders Systemic inflammatory response syndrome	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Hypertension	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2125 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Peripheral arterial occlusive disease	0.14% 3/2144 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2124 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Deep vein thrombosis	0.19% 4/2144 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Hypertensive crisis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Aortic aneurysm	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2125 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Hypotension	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Aortic dissection	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Arteriosclerosis	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Circulatory collapse	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Hypertensive urgency	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Iliac artery occlusion	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Peripheral Ischaemia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Peripheral vascular disorder	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Accelerated hypertension	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Aortic arteriosclerosis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Aortic stenosis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Haematoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Peripheral artery occlusion	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Peripheral artery stenosis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Shock Haemorrhagic	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Subclavian artery stenosis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Vascular disorders Thrombophlebitis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Osteorthritis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2125 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2136 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Back pain	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Osteonecrosis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2125 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Bursitis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Costochondritis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Spinal ligament	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Hepatobiliary disorders Cholecystitis acute	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2125 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2136 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Hepatobiliary disorders Cholelithiasis	0.14% 3/2144 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2125 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Hepatobiliary disorders Cholecystitis	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Hepatobiliary disorders Hepatic cirrohsis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Hepatobiliary disorders Bile duct obstruction	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Hepatobiliary disorders Cholangitis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Hepatobiliary disorders Cholecystitis Chronic	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Hepatobiliary disorders Hepatic failure	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Hepatobiliary disorders Hepatic function abnormal	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Hepatobiliary disorders Hepatitis toxic	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Renal and urinary disorders Nephrolithiasis	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2125 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Renal and urinary disorders Renal failure	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Renal and urinary disorders Acute kidney injury	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Renal and urinary disorders Urinary retention	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Renal and urinary disorders Renal colic	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Renal and urinary disorders Anuria	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Renal and urinary disorders Chronic kidney disease	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Renal and urinary disorders Haemorrhage urinary tract	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Renal and urinary disorders Hydronephrosis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Renal and urinary disorders Lower urinary tract symptoms	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Renal and urinary disorders Ureterolithiasis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Renal and urinary disorders Urinary bladder haemorrhage	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Metabolism and nutrition disorders Fluid overload	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Metabolism and nutrition disorders Hyperglycaemia	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Metabolism and nutrition disorders Hypoglycaemia	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Metabolism and nutrition disorders Hyponatremia	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Metabolism and nutrition disorders Dehydration	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Metabolism and nutrition disorders Diabetes melitus	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Metabolism and nutrition disorders Diabetes melitus inadequate control	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Metabolism and nutrition disorders Hyperlipidemia	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Metabolism and nutrition disorders Impaired fasting glucose	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Metabolism and nutrition disorders Obesity	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Blood and lymphatic system disorders Anaemia	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Blood and lymphatic system disorders Iron deficiancy anaemia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Blood and lymphatic system disorders Anaemia macrocytic	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Blood and lymphatic system disorders Immune thrombocytopenic purpura	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Blood and lymphatic system disorders Neutropenia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Psychiatric disorders Schizoaffective disorder	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Psychiatric disorders Suicidal ideation	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Psychiatric disorders Suicicide attempt	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Psychiatric disorders Affective disorder	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Psychiatric disorders Alcoholism	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Psychiatric disorders Hallucination	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Psychiatric disorders Persistent depressive disorder	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Eye disorders Cataract	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Eye disorders Retinal detachment	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Eye disorders Eyelid ptosis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Eye disorders Retinal vascular thrombosis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Eye disorders Visual impairment	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Investigations Troponin increased	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Investigations Blood folate decreased	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Investigations Blood magnesium decreased	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Investigations Electrocradiogram ST-T change	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Investigations Electrocardiogram abnormal	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Investigations Oxygen saturation decreased	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Investigations Prothrombin time abnormal	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Immune system disorders Drug hypersensitivity	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Immune system disorders Anaphylactic reaction	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Immune system disorders Allergy to arthropod sting	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Immune system disorders Type I hypersensitivity	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Reproductive system and breast disorders Benign prostatic hyperplasia	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Reproductive system and breast disorders Ovarian Cyst	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Reproductive system and breast disorders Scrotal cyst	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Reproductive system and breast disorders Vaginal leukoplakia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Ear and labyrinth disorders Vertigo	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Endocrine disorders Adrenal mass	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Endocrine disorders Goitre	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Pneumonia streptococcal	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Cor pulmonale	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkins lymphoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Rib fracture	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Contussion	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Penetrating abdominal trauma	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Pneumoconiosis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Thermal burn	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Wound evisceration	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Transient ischaemic attack	0.14% 3/2144 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Erosive oesophagitis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Large intestinal haemorrhage	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Renal and urinary disorders Glomerulonephritis chronic	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Eye disorders Retinal degeneration	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Pnuemonia aspiration	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Tricuspid valve incompetence	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Trifascicular black	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Ventricular tachycardia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	9.4% 202/2144 • Number of events 255 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	10.4% 221/2124 • Number of events 263 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	10.3% 219/2125 • Number of events 268 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	11.3% 241/2136 • Number of events 299 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.65% 14/2144 • Number of events 16 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.94% 20/2124 • Number of events 20 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.94% 20/2125 • Number of events 20 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.33% 7/2136 • Number of events 7 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.47% 10/2144 • Number of events 10 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.42% 9/2124 • Number of events 9 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.24% 5/2125 • Number of events 5 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.42% 9/2136 • Number of events 9 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Pulmonary emboism	0.19% 4/2144 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2124 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.24% 5/2125 • Number of events 5 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2124 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2125 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2136 • Number of events 6 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2125 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Hypoxia	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2124 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.14% 3/2144 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Laryngeal polyp	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Vocal cord leukoplakia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Bronchial secretion retention	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Cystic lung disease	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Nasal turbinate hypertrophy	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Pleurtitic pain	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Pulmonary calcification	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Pneumonia	2.8% 61/2144 • Number of events 63 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	2.8% 59/2124 • Number of events 64 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	1.6% 35/2125 • Number of events 37 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	2.6% 55/2136 • Number of events 57 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Sepsis	0.33% 7/2144 • Number of events 8 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.24% 5/2124 • Number of events 5 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.24% 5/2125 • Number of events 5 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2136 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Cellulitis	0.19% 4/2144 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.28% 6/2124 • Number of events 6 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2125 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2136 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Influenza	0.19% 4/2144 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.33% 7/2136 • Number of events 7 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Diverticulitis	0.14% 3/2144 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2124 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2125 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2136 • Number of events 5 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Bronchitis	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2124 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2125 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2136 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Urinary tract infection	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2124 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Respiratory tract infection	0.09% 2/2144 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Lung infection	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Lower respiratory tract infection	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Appendicitis	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Septic shock	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Erysipelas	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Pneumonia bacterial	0.14% 3/2144 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Pneumonia viral	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Staphylococcal infection	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2125 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Wound infection	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Anal abscess	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Device related infection	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Gastroenteritis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Peritonitis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Pneumonia pneumococcal	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Pulmonary tuberculosis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Respiratory syncytial virus infection	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Urosepsis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Arthritis bacterial	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Bacterial pyelonephritis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Bronchitis viral	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Bronchopulmonary aspergillosis allergic	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Bursitis infective	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Campylobacter infection	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Catheter site cellulitits	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Cellulitis of male external genital organ	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Cholecystitis infective	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Clostridium difficile colitis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Colonic abscess	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Emphysematous cholecystitis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Encephalitis brain stem	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Endocarditis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Epididymitis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Gastroenteritis norovirus	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Gastroenteritis salmonella	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Gastroenteritis shigella	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Gastroenteritis viral	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations H1N1 influenza	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Histoplasmosis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Infected bite	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Infected dermal cyst	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Infective exacerbation of bronshiectasis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Laryngitis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Localised infection	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Mastitis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Mastoiditis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Metapneumovirus infection	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Micrococcus infection	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Oesophageal candidiasis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Osteomyelitis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Otosalpingitis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Perichondritis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Periorbital cellulitis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Pneumonia pseudomonal	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Post procedural sepsis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Pyelonephritis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Respiratory tract infection viral	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Sinusitis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Soft tissue infection	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Tracheobronchitis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Vaginal infection	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Viral infection	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Acute myocardial infarction	0.33% 7/2144 • Number of events 8 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.47% 10/2124 • Number of events 10 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.80% 17/2125 • Number of events 18 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.33% 7/2136 • Number of events 7 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Atrial fibrilation	0.42% 9/2144 • Number of events 9 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.38% 8/2124 • Number of events 8 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.66% 14/2125 • Number of events 15 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2136 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Myocardial infarction	0.23% 5/2144 • Number of events 5 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.24% 5/2124 • Number of events 5 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.33% 7/2125 • Number of events 7 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2136 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Coronary artery disease	0.23% 5/2144 • Number of events 5 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.24% 5/2124 • Number of events 5 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.33% 7/2125 • Number of events 7 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Cardiac failure congestive	0.23% 5/2144 • Number of events 6 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2124 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.24% 5/2125 • Number of events 6 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Cardiac arrest	0.14% 3/2144 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.38% 8/2125 • Number of events 8 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Angina pectoris	0.14% 3/2144 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2125 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.23% 5/2136 • Number of events 5 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Cardiac failure	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2124 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2136 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Angina unstable	0.14% 3/2144 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2125 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Cardiac failure acute	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2125 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Cardiorespiratory arrest	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2125 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Acute coronary syndrome	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2124 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Stress cardiomyopathy	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2124 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Arteriosclerosis coronary artery	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Atrial flutter	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Supraventricular tachycardia	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Arrhythmia	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Bradycardia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Acute left ventricular failure	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Atrioventricular block complete	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Coronary artery occulsion	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Myocardial ischaemia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Pulseless electrical activity	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Ventricular fibrillation	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Atriventricular block second degree	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Cardiac disorder	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Cardio-respiratory distress	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Cardiac failure chronic	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Cardiogenic shock	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Cardiovascular disorder	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Cardiovascular insufficency	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Coronary artery stenosis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Hypertensive heart disease	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Ischaemic cardiomyopathy	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Left ventricular failure	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Mitral valve incompetence	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Myocarditis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Right ventricular failure	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Sinus node dysfunction	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Cardiac disorders Tachycardia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.19% 4/2144 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.24% 5/2124 • Number of events 5 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2136 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.14% 3/2144 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2136 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2125 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 12 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung caner	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant palate neoplasm	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Abdominal wall neoplasm	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenosquamous cell lung cancer	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage IV	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neopplasm	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal lymphoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrooesophageal cancer	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive breast carcinoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metasteses to bone	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to nervous system	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal cancer metastatic	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oropharyngeal squamous cell carcinoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary renal cell carcinoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Recosigmoid cancer	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Hip fracture	0.19% 4/2144 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2124 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.23% 5/2136 • Number of events 5 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Ankle fracture	0.14% 3/2144 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2136 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Fall	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Femoral neck fracture	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Femur fracture	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Lower limb fracture	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Radius fracture	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Road traffic accident	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Spinal compression fracture	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Abdominal wound dehiscene	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Foot fracture	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Post procedural hemorrhage	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Concussion	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Epicondylitis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Foreign body aspiration	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Hand Fracture	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Humerous fracture	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Joint dislocation	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Limb traumatic amputation	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Ocular procedural complication	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Procedural pneumothorax	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Radiation proctitis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Subdural hematoma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Tendon rupture	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Venomous bite	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Wound decomposition	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Injury, poisoning and procedural complications Wrist fracture	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Cerebrovascular accident	0.37% 8/2144 • Number of events 8 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2125 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2136 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Syncope	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.14% 3/2124 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2136 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Cerebral infarction	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.23% 5/2136 • Number of events 5 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Carotid artery stenosis	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Siezure	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.19% 4/2124 • Number of events 4 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Encephalopathy	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Cerebellar infarction	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Dizziness	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Subarachnoid haemorrhage	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Ataxia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Cerebral ischaemia	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Intracranial aneurysm	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Ischaemic stroke	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Aphasia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Brain injury	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Carpal tunnel syndrome	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Cerebral haemorrhage	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Cerebrospinal fluid leakage	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Cervical radiculopathy	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Colloid brain cyst	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Embolic Cerebral infarction	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Epilepsy	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Guillain-Barre syndrome	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Haemorrhage intercranial	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Hemorrhagic stroke	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Headache	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Hemiparesis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Hyopercapnic coma	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Intercostal neuralgia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Lacunar infarction	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Loss of consciousness	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Lumbar radiculopathy	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Monparesis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Myelopathy	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Ruptured cerebral aneurysm	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Sciatica	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Spinal claudication	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Nervous system disorders Vocal cord paralysis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Gastrointestinal haemorrhage	0.09% 2/2144 • Number of events 3 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Small intestine obstruction	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2136 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Abdonimal pain	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2125 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Inguinal hernia	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Colitis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Pancreatitis acute	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Constipation	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Enteritis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Abdominal hernia	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Colitis ulcerative	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Diverticular perforation	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Duodenal ulcenrn	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Ileus	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.09% 2/2124 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Large intestine polyp	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Anal fissure	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Colitis microscopic	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Diaphragmatic hernia	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Diverticulum	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Duodenal perforation	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Dysphagia	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Enterocolitis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Gastric ulcer	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Gastric ulcer perforation	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Gastritis	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Haemoroidal haemorrhage	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Haemorrhoids thrombosed	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Intestinal Infarction	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Intestinal obstruction	0.09% 2/2144 • Number of events 2 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2125 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Intestinal polyp	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Mesenteric artery stenosis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2136 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Obstructive pancreatitis	0.00% 0/2144 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.05% 1/2124 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Gastrointestinal disorders Pharyngo-oesophageal diverticulum	0.05% 1/2144 • Number of events 1 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2124 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2125 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	0.00% 0/2136 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug

Other adverse events

Measure	BGF MDI 320/14.4/9.6 μg n=2144 participants at risk Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/14.4/9.6 μg	BGF MDI 160/14.4/9.6 μg n=2124 participants at risk Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 160/14.4/9.6 μg	GFF MDI 14.4/9.6 μg n=2125 participants at risk Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 14.4/9.6 μg	BFF MDI 320/9.6 μg n=2136 participants at risk Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhalation 320/9.6 μg
Infections and infestations Nasopharyngitis	10.6% 227/2144 • Number of events 290 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	11.3% 239/2124 • Number of events 315 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	9.4% 199/2125 • Number of events 255 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	11.0% 234/2136 • Number of events 331 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug
Infections and infestations Upper respiratory tract infection	5.7% 123/2144 • Number of events 149 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	6.5% 137/2124 • Number of events 176 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	4.8% 102/2125 • Number of events 129 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug	5.4% 115/2136 • Number of events 154 • Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug

Additional Information

Pearl Therapeutics Inc

Pearl Therapeutics Inc

Phone: 1-877-240-9479

Email: information.center@astrazeneca.com

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