Trial Outcomes & Findings for QUILT-2.013: First-Line Treatment for Extensive Stage Small Cell Lung Cancer (NCT NCT00791154)

NCT ID: NCT00791154

Last Updated: 2024-08-23

Results Overview

The primary efficacy endpoint was overall survival, defined as time from randomization to death from any cause

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 213 participants
• Primary outcome timeframe: Time from randomization to death from any cause, approximately 14 months
• Results posted on: 2024-08-23

Participant Flow

Participant milestones

Measure	Phase 1: AMG 479/Carboplatin+Etoposide AMG 479 in combination with etoposide plus carboplatin (Cohort 1)	Phase 1: AMG 479/Cisplatin+Etoposide cisplatin (Cohort 2)	Phase 1: AMG102/Carboplatin+Etoposide AMG 102 in combination with etoposide plus carboplatin (Cohort 3)	Phase 1: AMG 102/Cisplatin+Etoposide cisplatin (Cohort 4)	Phase 2 Ganitumab Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide	Phase 2 Rilotumumab Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide	Phase 2 Placebo Blinded placebo and carboplatin or cisplatin and etoposide
Overall Study STARTED	6	8	6	8	62	62	61
Overall Study COMPLETED	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	6	8	6	8	62	62	61

Reasons for withdrawal

Measure	Phase 1: AMG 479/Carboplatin+Etoposide AMG 479 in combination with etoposide plus carboplatin (Cohort 1)	Phase 1: AMG 479/Cisplatin+Etoposide cisplatin (Cohort 2)	Phase 1: AMG102/Carboplatin+Etoposide AMG 102 in combination with etoposide plus carboplatin (Cohort 3)	Phase 1: AMG 102/Cisplatin+Etoposide cisplatin (Cohort 4)	Phase 2 Ganitumab Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide	Phase 2 Rilotumumab Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide	Phase 2 Placebo Blinded placebo and carboplatin or cisplatin and etoposide
Overall Study Noncompliance	0	1	0	0	1	1	1
Overall Study Adverse Event	0	0	0	0	2	0	1
Overall Study Full Consent withdrawn	1	3	0	0	1	3	1
Overall Study Lost to Follow-up	0	0	0	1	2	0	4
Overall Study Death	5	4	4	7	54	54	52
Overall Study Other event	0	0	2	0	2	4	2

Baseline Characteristics

QUILT-2.013: First-Line Treatment for Extensive Stage Small Cell Lung Cancer

Baseline characteristics by cohort

Measure	Phase 1: AMG 479/Carboplatin+Etoposide n=6 Participants AMG 479 in combination with etoposide plus carboplatin (Cohort 1)	Phase 1: AMG 479/Cisplatin+Etoposide n=8 Participants cisplatin (Cohort 2)	Phase 1: AMG102/Carboplatin+Etoposide n=6 Participants AMG 102 in combination with etoposide plus carboplatin (Cohort 3)	Phase 1: AMG 102/Cisplatin+Etoposide n=8 Participants cisplatin (Cohort 4)	Phase 2 Ganitumab n=62 Participants Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide	Phase 2 Rilotumumab n=62 Participants Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide	Phase 2 Placebo n=61 Participants Blinded placebo and carboplatin or cisplatin and etoposide	Total n=213 Participants Total of all reporting groups
Age, Continuous	63.3 years STANDARD_DEVIATION 7.3 • n=5 Participants	55.4 years STANDARD_DEVIATION 9.0 • n=7 Participants	60.7 years STANDARD_DEVIATION 8.0 • n=5 Participants	59.4 years STANDARD_DEVIATION 5.0 • n=4 Participants	59.8 years STANDARD_DEVIATION 7.6 • n=21 Participants	60.8 years STANDARD_DEVIATION 7.6 • n=10 Participants	59.6 years STANDARD_DEVIATION 9.7 • n=115 Participants	60.1 years STANDARD_DEVIATION 8.3 • n=6 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	14 Participants n=21 Participants	15 Participants n=10 Participants	14 Participants n=115 Participants	54 Participants n=6 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	48 Participants n=21 Participants	47 Participants n=10 Participants	47 Participants n=115 Participants	159 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	13 Participants n=21 Participants	13 Participants n=10 Participants	6 Participants n=115 Participants	38 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	48 Participants n=21 Participants	49 Participants n=10 Participants	55 Participants n=115 Participants	174 Participants n=6 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	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants
Histologically or cytologically confirmed SCLC	6 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	62 Participants n=21 Participants	62 Participants n=10 Participants	61 Participants n=115 Participants	212 Participants n=6 Participants

PRIMARY outcome

Timeframe: Time from randomization to death from any cause, approximately 14 months

The primary efficacy endpoint was overall survival, defined as time from randomization to death from any cause

Outcome measures

Measure	Phase 2 Ganitumab n=62 Participants Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide	Phase 2 Placebo n=61 Participants Blinded placebo and carboplatin or cisplatin and etoposide	Phase 1: AMG102/Carboplatin+Etoposide AMG 102 in combination with etoposide plus carboplatin (Cohort 3)	Phase 1: AMG 102/Cisplatin+Etoposide AMG 102 in combination with etoposide plus carboplatin (Cohort 3) or cisplatin (Cohort 4)	Phase 2 Rilotumumab Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide	Phase 2 Placebo Blinded placebo and carboplatin or cisplatin and etoposide	Phase 2 Placebo Blinded placebo and carboplatin or cisplatin and etoposide
Overall Survival in Ganitumab Treated Subjects -Phase 2	10.7 months Interval 8.1 to 14.1	10.8 months Interval 9.4 to 11.9	—	—	—	—	—

PRIMARY outcome

Timeframe: Time from randomization to death from any cause, approximately 14 months

Population: This endpoint was phase 2 subjects only

The primary efficacy endpoint is overall survival, defined as time from randomization to death from any cause

Outcome measures

Measure	Phase 2 Ganitumab Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide	Phase 2 Placebo Blinded placebo and carboplatin or cisplatin and etoposide	Phase 1: AMG102/Carboplatin+Etoposide AMG 102 in combination with etoposide plus carboplatin (Cohort 3)	Phase 1: AMG 102/Cisplatin+Etoposide AMG 102 in combination with etoposide plus carboplatin (Cohort 3) or cisplatin (Cohort 4)	Phase 2 Rilotumumab n=62 Participants Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide	Phase 2 Placebo n=61 Participants Blinded placebo and carboplatin or cisplatin and etoposide	Phase 2 Placebo Blinded placebo and carboplatin or cisplatin and etoposide
Overall Survival in Rilotumumab Treated Subjects-Phase 2	—	—	—	—	12.2 months Interval 8.8 to 14.6	10.8 months Interval 9.4 to 11.9	—

PRIMARY outcome

Timeframe: First 21 days after start of study treatment

Population: This endpoint is for phase 1 subjects only

For Part 1, DLTs were defined as the incidence during the first 21 days of starting study treatment of any Grade 3 or higher hematologic or non-hematologic toxicity related to AMG 479 or AMG 102, or the combination of AMG 479 or AMG 102 with chemotherapy, except for lymphocytopenia and anemia. DLTs did not include fatigue, nausea, diarrhea, vomiting, hyperglycemia, neutropenia, thrombocytopenia, increased AST or ALT, or pulmonary embolism unless specific criteria were met as stated in protocol section 6.1.3.2.

Outcome measures

Measure	Phase 2 Ganitumab n=6 Participants Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide	Phase 2 Placebo n=7 Participants Blinded placebo and carboplatin or cisplatin and etoposide	Phase 1: AMG102/Carboplatin+Etoposide n=6 Participants AMG 102 in combination with etoposide plus carboplatin (Cohort 3)	Phase 1: AMG 102/Cisplatin+Etoposide n=8 Participants AMG 102 in combination with etoposide plus carboplatin (Cohort 3) or cisplatin (Cohort 4)	Phase 2 Rilotumumab Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide	Phase 2 Placebo Blinded placebo and carboplatin or cisplatin and etoposide	Phase 2 Placebo Blinded placebo and carboplatin or cisplatin and etoposide
Number of Subjects With Dose Limiting Toxicities-Phase 1	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Phase 1: AMG 479/Carboplatin+Etoposide

Serious events: 5 serious events

Other events: 6 other events

Deaths: 5 deaths

Phase 1: AMG 479/Cisplatin+Etoposide

Serious events: 2 serious events

Other events: 6 other events

Deaths: 4 deaths

Phase 1: AMG102/Carboplatin+Etoposide

Serious events: 4 serious events

Other events: 6 other events

Deaths: 4 deaths

Phase 1: AMG 102/Cisplatin+Etoposide

Serious events: 7 serious events

Other events: 8 other events

Deaths: 7 deaths

Phase 2 Ganitumab

Serious events: 7 serious events

Other events: 58 other events

Deaths: 54 deaths

Phase 2 Rilotumumab

Serious events: 6 serious events

Other events: 61 other events

Deaths: 54 deaths

Phase 2 Placebo

Serious events: 3 serious events

Other events: 57 other events

Deaths: 52 deaths

Serious adverse events

Measure	Phase 1: AMG 479/Carboplatin+Etoposide n=6 participants at risk combination with etoposide plus carboplatin (Cohort 1)	Phase 1: AMG 479/Cisplatin+Etoposide n=7 participants at risk Phase 1: AMG 479/Cisplatin+Etoposide cisplatin (Cohort 2)	Phase 1: AMG102/Carboplatin+Etoposide n=6 participants at risk AMG 102 in combination with etoposide plus carboplatin (Cohort 3)	Phase 1: AMG 102/Cisplatin+Etoposide n=8 participants at risk Phase 1: AMG 102/Cisplatin+Etoposide cisplatin (Cohort 4)	Phase 2 Ganitumab n=59 participants at risk Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide	Phase 2 Rilotumumab n=61 participants at risk Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide	Phase 2 Placebo n=59 participants at risk Blinded placebo and carboplatin or cisplatin and etoposide
Cardiac disorders Arrhythmia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	3.4% 2/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	1.6% 1/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Pancytopenia	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	1.6% 1/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Cardiac disorders Cardiac Arrest	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	1.6% 1/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Gastric Ulcer Haemorrhage	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	1.7% 1/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Gastroenteritis	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	1.7% 1/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Pneumonia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Septic Shock	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm Progression	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	1.7% 1/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small Cell Lung Cancer Stage Unspecified	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	1.6% 1/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	1.7% 1/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Cerebrovascular Accident	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	1.6% 1/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	1.7% 1/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Pulmonary Haemorrhage	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	3.4% 2/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Leukopenia	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Neutropenia	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Urinary Tract Infection	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Cardiac disorders Atrial Fibrillation	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Cardiac disorders Ventricular Extrasystoles	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Nausea	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Fatigue	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Malaise	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Lower Respiratory Tract Infection	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Pyelonephritis	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Sepsis	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Septic Embolus	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Staphylococcal Infection	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Injury, poisoning and procedural complications Medication Error	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Metabolism and nutrition disorders Tumour Lysis Syndrome	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Presyncope	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Syncope	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Haemoptysis	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Lung Disorder	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	37.5% 3/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Vascular disorders Superior Vena Cava Syndrome	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Vascular disorders Venous Thrombosis Limb	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.

Other adverse events

Measure	Phase 1: AMG 479/Carboplatin+Etoposide n=6 participants at risk combination with etoposide plus carboplatin (Cohort 1)	Phase 1: AMG 479/Cisplatin+Etoposide n=7 participants at risk Phase 1: AMG 479/Cisplatin+Etoposide cisplatin (Cohort 2)	Phase 1: AMG102/Carboplatin+Etoposide n=6 participants at risk AMG 102 in combination with etoposide plus carboplatin (Cohort 3)	Phase 1: AMG 102/Cisplatin+Etoposide n=8 participants at risk Phase 1: AMG 102/Cisplatin+Etoposide cisplatin (Cohort 4)	Phase 2 Ganitumab n=59 participants at risk Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide	Phase 2 Rilotumumab n=61 participants at risk Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide	Phase 2 Placebo n=59 participants at risk Blinded placebo and carboplatin or cisplatin and etoposide
Gastrointestinal disorders Dyspepsia	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Dysphagia	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Nausea	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	57.1% 4/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	50.0% 3/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	62.5% 5/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Diarrhoea	66.7% 4/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	37.5% 3/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Skin and subcutaneous tissue disorders Alopecia	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	57.1% 4/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	50.0% 3/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	62.5% 5/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Vomiting	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	25.0% 2/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Thrombocytopenia	66.7% 4/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	25.0% 2/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Investigations Weight Decreased	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	50.0% 4/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	28.6% 2/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	25.0% 2/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Asthenia	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	50.0% 3/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	50.0% 4/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Constipation	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	42.9% 3/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	37.5% 3/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Metabolism and nutrition disorders Decreased Appetite	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	50.0% 4/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Stomatitis	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	10.2% 6/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	1.7% 1/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Pyrexia	66.7% 4/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Hyperglycaemia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	8.5% 5/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	3.3% 2/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	1.7% 1/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Epigastric Discomfort	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	25.0% 2/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	6.8% 4/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	1.6% 1/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Back Pain	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	6.8% 4/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	8.2% 5/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	11.9% 7/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Psychiatric disorders Insomnia	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Oropharyngeal Pain	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	3.4% 2/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	4.9% 3/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	8.5% 5/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Psychiatric disorders Anxiety	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Ear and labyrinth disorders Deafness	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	5.1% 3/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Investigations Hypokalaemia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	5.1% 3/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	9.8% 6/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Ear and labyrinth disorders Ototoxicity	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	5.1% 3/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	1.6% 1/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Ear and labyrinth disorders Tinnitus	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	37.5% 3/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	5.1% 3/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Headache	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	13.6% 8/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	8.2% 5/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	8.5% 5/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Leukopenia	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	8.5% 5/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	8.2% 5/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	13.6% 8/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Hyponatraemia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	5.1% 3/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	1.6% 1/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	8.5% 5/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Investigations Alanine Aminotransferase Increased	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	3.4% 2/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	8.2% 5/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	25.0% 2/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	10.2% 6/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	4.9% 3/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	11.9% 7/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Fatigue	50.0% 3/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	66.7% 4/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	1.7% 1/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	11.5% 7/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	3.4% 2/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Neutropenia	50.0% 3/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	57.1% 4/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	83.3% 5/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	62.5% 5/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	69.5% 41/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	59.0% 36/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	71.2% 42/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Vascular disorders Oedema Peripheral	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	3.4% 2/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	13.1% 8/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	3.4% 2/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Anaemia	66.7% 4/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	28.6% 2/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	50.0% 3/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	50.0% 4/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Anaemia Macrocytic	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Febrile Neutropenia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Haemoglobinaemia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Leukocytosis	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Lymphopenia	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Blood and lymphatic system disorders Pancytopenia	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Cardiac disorders Arrhythmia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Cardiac disorders Atrial Fibrillation	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Cardiac disorders Sinus Tachycardia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Cardiac disorders Ventricular Extrasystoles	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Ear and labyrinth disorders Hypoacusis	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Ear and labyrinth disorders Vertigo	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Eye disorders Dry Eye	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Endocrine disorders Inappropriate Antidiuretic Hormone Secretion	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Eye disorders Asthenopia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Eye disorders Conjunctivitis	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Eye disorders Eye Pain	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Eye disorders Eyelid Disorder	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Eye disorders Eyelid Oedema	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Eye disorders Vision Blurred	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Abdominal Pain	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	25.0% 2/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Aphthous Stomatitis	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Chapped Lips	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Dry Mouth	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Stomatitis	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Gingival Bleeding	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Oesophagitis	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Gastrointestinal disorders Oral Disorder	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Catheter Site Inflammation	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Chest Discomfort	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Chest Pain	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Chills	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Face Oedema	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Infusion Site Extravasation	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Irritability	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Malaise	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Mucosal Inflammation	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Nodule	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
General disorders Oedema Peripheral	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	37.5% 3/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Hepatobiliary disorders Cytolytic Hepatitis	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Balanitis Candida	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Enterocolitis Bacterial	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Gastroenteritis	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Infection	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Lower Respiratory Tract Infection	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Oral Fungal Infection	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Pharyngitis	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Pneumonia	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Pyelonephritis	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Respiratory Tract Infection	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Rhinitis	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	25.0% 2/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Sepsis	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Septic Embolus	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Septic Shock	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Sinusitis	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Staphylococcal Infection	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Infections and infestations Urinary Tract Infection	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Injury, poisoning and procedural complications Excoriation	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Injury, poisoning and procedural complications Medication Error	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Injury, poisoning and procedural complications Post Procedural Complication	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Injury, poisoning and procedural complications Wound	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Investigations Wound	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Investigations Blood Creatinine Increased	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	25.0% 2/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Investigations Blood Pressure Increased	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Investigations Brain Natriuretic Peptide Increased	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Investigations Glomerular Filtration Rate Decreased	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Investigations Platelet Count Increased	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Investigations Troponin Increased	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Investigations Troponin T Increased	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Metabolism and nutrition disorders Dehydration	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Metabolism and nutrition disorders Fluid Overload	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Metabolism and nutrition disorders Hyperamylasaemia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Metabolism and nutrition disorders Hyperglycaemia	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Metabolism and nutrition disorders Hyperkalaemia	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Metabolism and nutrition disorders Hyperuricaemia	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Metabolism and nutrition disorders Hypocalcaemia	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Metabolism and nutrition disorders Hypokalaemia	50.0% 3/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Metabolism and nutrition disorders Hypomagnesaemia	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Metabolism and nutrition disorders Hyponatraemia	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Metabolism and nutrition disorders Tumour Lysis Syndrome	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Metabolism and nutrition disorders Weight Fluctuation	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Musculoskeletal and connective tissue disorders Back Pain	50.0% 3/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	25.0% 2/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Musculoskeletal and connective tissue disorders Bone Pain	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Musculoskeletal and connective tissue disorders Muscle Spasms	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Musculoskeletal and connective tissue disorders Muscular Weakness	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Musculoskeletal and connective tissue disorders Pain In Jaw	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Dizziness	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Dysgeusia	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Dysgraphia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Formication	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Headache	66.7% 4/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	42.9% 3/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Hypoaesthesia	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Lethargy	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Memory Impairment	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Migraine	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Neuropathy Peripheral	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Paraesthesia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Presyncope	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Sciatica	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Somnolence	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Syncope	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Nervous system disorders Tremor	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Psychiatric disorders Agitation	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Bronchitis Chronic	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Reproductive system and breast disorders Cough	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	28.6% 2/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	37.5% 3/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Haemoptysis	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	28.6% 2/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Lung Disorder	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Productive Cough	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	50.0% 4/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Pulmonary Thrombosis	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Respiratory Disorder	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Respiratory Distress	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Sputum Discoloured	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Respiratory, thoracic and mediastinal disorders Wheezing	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Skin and subcutaneous tissue disorders Dry Skin	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Skin and subcutaneous tissue disorders Dyshidrosis	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Skin and subcutaneous tissue disorders Ecchymosis	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Skin and subcutaneous tissue disorders Night Sweats	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	14.3% 1/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Skin and subcutaneous tissue disorders Pruritus	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Skin and subcutaneous tissue disorders Skin Ulcer	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Skin and subcutaneous tissue disorders Urticaria	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Vascular disorders Haematoma	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Vascular disorders Hypertension	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Vascular disorders Hypotension	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	33.3% 2/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Vascular disorders Superior Vena Cava Syndrome	16.7% 1/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.
Vascular disorders Venous Thrombosis Limb	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/7 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/6 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	12.5% 1/8 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/61 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.	0.00% 0/59 • All serious adverse events that occur after the subject has signed the informed consent form through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. All non-serious adverse events that occur after the subject has enrolled through to the Safety Follow-up Visit or 30 days after completion of the study treatment phase, approximately 14 months. The Safety population was used for adverse event reporting (i.e., all subjects that had at least one dose of study drug). All subjects were measured for mortality.

Additional Information

Sandeep Bobby Reddy, Chief Medical Officer

ImmunityBio

Phone: 855-797-9277

Email: Bobby.Reddy@immunitybio.com

Results disclosure agreements

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