Trial Outcomes & Findings for A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients (NCT NCT01014975)

NCT ID: NCT01014975

Last Updated: 2015-10-21

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

40 participants

Primary outcome timeframe

90 days

Results posted on

2015-10-21

Participant Flow

Participant milestones

Participant milestones
Measure	20 mg Plasmin (Human) 20 mg of Plasmin (Human) Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus	40 mg Plasmin (Human) 40 mg of Plasmin (Human) Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus	80 mg Plasmin (Human) 80 mg of Plasmin (Human) Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus
Overall Study STARTED	8	16	16
Overall Study COMPLETED	4	13	10
Overall Study NOT COMPLETED	4	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	20 mg Plasmin (Human) 20 mg of Plasmin (Human) Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus	40 mg Plasmin (Human) 40 mg of Plasmin (Human) Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus	80 mg Plasmin (Human) 80 mg of Plasmin (Human) Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus
Overall Study Withdrawal by Subject	1	0	1
Overall Study Death	3	3	4
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

A Safety and Dose Finding Study of Plasmin (Human) Administered Into the Middle Cerebral Artery of Stroke Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Safety Population n=40 Participants Plasmin (Human): Plasmin (Human), 20 mg, 40 mg, or 80 mg, delivered through a catheter into a thrombus
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	32 Participants n=5 Participants
Age, Continuous	73.1 years STANDARD_DEVIATION 9.38 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment Serbia	10 participants n=5 Participants
Region of Enrollment France	7 participants n=5 Participants
Region of Enrollment Slovakia	5 participants n=5 Participants
Region of Enrollment Spain	8 participants n=5 Participants
Region of Enrollment Austria	1 participants n=5 Participants
Region of Enrollment Australia	5 participants n=5 Participants
Region of Enrollment Germany	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Population: Safety Population

Outcome measures

Outcome measures
Measure	20 mg Plasmin (Human) n=8 Participants 20 mg of Plasmin (Human) Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus	40 mg Plasmin (Human) n=16 Participants 40 mg of Plasmin (Human) Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus	80 mg Plasmin (Human) n=16 Participants 80 mg of Plasmin (Human) Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus
Incidence of Symptomatic Intracranial Hemorrhage (SICH) by Dose Cohort	0 participants	0 participants	0 participants

Adverse Events

20 mg Plasmin (Human)

Serious events: 6 serious events

Other events: 8 other events

Deaths: 0 deaths

40 mg Plasmin (Human)

Serious events: 7 serious events

Other events: 12 other events

Deaths: 0 deaths

80 mg Plasmin (Human)

Serious events: 7 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Henry Li, PhD

Grifols Therapeutics, Inc.

Phone: 800-520-2807

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Site may publish results from the study, after providing sponsor 30 days' notice prior to submitting a manuscript or other materials related to the study to any outside party. At sponsor's request, site will remove any confidential information (other than study results), and site will upon sponsor's request delay publication or presentation for a period of up to 120 days to allow sponsor to protect its interests in any sponsor inventions.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	20 mg Plasmin (Human) n=8 participants at risk 20 mg of Plasmin (Human) Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus	40 mg Plasmin (Human) n=16 participants at risk 40 mg of Plasmin (Human) Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus	80 mg Plasmin (Human) n=16 participants at risk 80 mg of Plasmin (Human) Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	12.5% 2/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Respiratory, thoracic and mediastinal disorders Aspiration	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Respiratory, thoracic and mediastinal disorders Bronchospasm	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Nervous system disorders Brain oedema	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Nervous system disorders Cerebral infarction	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Nervous system disorders Cerebrovascular accident	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Nervous system disorders Haemorrhagic cerebral infarction	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Cardiac disorders Cardiac arrest	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	12.5% 2/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Cardiac disorders Cardiac failure	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Vascular disorders Cardiopulmonary failure	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Gastrointestinal disorders Duodenal ulcer haemorrhage	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Gastrointestinal disorders Faecaloma	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Gastrointestinal disorders Gastric ulcer haemorrhage	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Gastrointestinal disorders Haematemesis	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Gastrointestinal disorders Melaena	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Psychiatric disorders Delirium	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Vascular disorders Arterial thrombosis limb	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.

Other adverse events
Measure	20 mg Plasmin (Human) n=8 participants at risk 20 mg of Plasmin (Human) Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus	40 mg Plasmin (Human) n=16 participants at risk 40 mg of Plasmin (Human) Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus	80 mg Plasmin (Human) n=16 participants at risk 80 mg of Plasmin (Human) Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus
Nervous system disorders HEADACHE	25.0% 2/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	12.5% 2/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Nervous system disorders CEREBRAL HAEMORRHAGE	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Nervous system disorders MUSCLE SPASTICITY	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Nervous system disorders CENTRAL PAIN SYNDROME	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Nervous system disorders CEREBRAL INFARCTION	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Nervous system disorders COMPLEX REGIONAL PAIN SYNDROME	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Nervous system disorders HAEMORRHAGE INTRACRANIAL	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Nervous system disorders HAEMORRHAGIC CEREBRAL INFARCTION	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Nervous system disorders HYPERTONIA	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Nervous system disorders NEURALGIA	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Nervous system disorders VASCULAR DEMENTIA	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Gastrointestinal disorders CONSTIPATION	62.5% 5/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Gastrointestinal disorders NAUSEA	25.0% 2/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	12.5% 2/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Gastrointestinal disorders DIARRHOEA	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	12.5% 2/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Gastrointestinal disorders FAECAL INCONTINENCE	25.0% 2/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Gastrointestinal disorders ABDOMINAL PAIN	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Gastrointestinal disorders HAEMATEMESIS	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Gastrointestinal disorders MELAENA	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Gastrointestinal disorders VOMITING	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Cardiac disorders ATRIAL FIBRILLATION	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	12.5% 2/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Cardiac disorders BRADYCARDIA	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Cardiac disorders CARDIAC FAILURE	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Cardiac disorders TACHYCARDIA	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Cardiac disorders VENTRICULAR TACHYCARDIA	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
General disorders PYREXIA	37.5% 3/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	12.5% 2/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	31.2% 5/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
General disorders OEDEMA PERIPHERAL	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	12.5% 2/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
General disorders CHEST PAIN	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
General disorders DRUG INTOLERANCE	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Infections and infestations URINARY TRACT INFECTION	25.0% 2/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	18.8% 3/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Infections and infestations BRONCHITIS	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Infections and infestations ORAL CANDIDIASIS	25.0% 2/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Infections and infestations ABSCESS ORAL	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Infections and infestations BACTERAEMIA	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Infections and infestations BACTERIAL INFECTION	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Infections and infestations CANDIDIASIS	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Infections and infestations FUNGAL SKIN INFECTION	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Infections and infestations INFECTION	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Infections and infestations KERATITIS HERPETIC	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	12.5% 1/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.
Infections and infestations ORCHITIS	0.00% 0/8 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	0.00% 0/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.	6.2% 1/16 • Adverse events were collected from the time of signing the informed consent form up to the last day of the study, including the follow-up and off-study medication period, 90 days after treatment. Treatment-emergent adverse events were adverse events reported after the subject received study medication.