Trial Outcomes & Findings for Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma (NCT NCT03077685)

NCT ID: NCT03077685

Last Updated: 2024-06-24

Results Overview

Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 54 participants
• Primary outcome timeframe: Up to Week 24 for Dose Escalation subjects; up to Week 28 for Second Phase subjects; up to 9 Months for Third Phase subjects.
• Results posted on: 2024-06-24

Participant Flow

Participant milestones

Measure	Dose Escalation: NanoPac® 6 mg/mL Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 10 mg/mL Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 15 mg/mL Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Second Phase: NanoPac® 15 mg/mL Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive two NanoPac® administrations, with the second injection administered one month after the first injection.	Third Phase: NanoPac® 15 mg/mL Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive up to four NanoPac® administrations, with injections administered one month apart.
Overall Study STARTED	3	3	4	25	19
Overall Study COMPLETED	2	3	2	19	8
Overall Study NOT COMPLETED	1	0	2	6	11

Reasons for withdrawal

Measure	Dose Escalation: NanoPac® 6 mg/mL Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 10 mg/mL Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 15 mg/mL Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Second Phase: NanoPac® 15 mg/mL Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive two NanoPac® administrations, with the second injection administered one month after the first injection.	Third Phase: NanoPac® 15 mg/mL Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive up to four NanoPac® administrations, with injections administered one month apart.
Overall Study Lost to Follow-up	0	0	0	0	1
Overall Study Death	0	0	1	1	3
Overall Study Withdrawal by Subject	0	0	0	2	1
Overall Study Physician Decision	0	0	1	0	3
Overall Study Disease Progression	1	0	0	2	1
Overall Study Withdrawn to proceed to surgery	0	0	0	1	1
Overall Study Subject entered hospice care	0	0	0	0	1

Baseline Characteristics

Trial of NanoPac® in Subjects With Locally Advanced Pancreatic Adenocarcinoma

Baseline characteristics by cohort

Measure	Dose Escalation: NanoPac® 6 mg/mL n=3 Participants Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 10 mg/mL n=3 Participants Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 15 mg/mL n=4 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Second Phase: NanoPac® 15 mg/mL n=25 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive two NanoPac® administrations, with the second injection administered one month after the first injection.	Third Phase: NanoPac® 15 mg/mL n=19 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive up to four NanoPac® administrations, with injections administered one month apart.	Total n=54 Participants Total of all reporting groups
Age, Continuous	64.0 years STANDARD_DEVIATION 9.00 • n=93 Participants	71.3 years STANDARD_DEVIATION 8.08 • n=4 Participants	72.0 years STANDARD_DEVIATION 9.56 • n=27 Participants	65.6 years STANDARD_DEVIATION 10.08 • n=483 Participants	71.3 years STANDARD_DEVIATION 11.19 • n=36 Participants	68.3 years STANDARD_DEVIATION 10.74 • n=10 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	11 Participants n=483 Participants	10 Participants n=36 Participants	22 Participants n=10 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants	14 Participants n=483 Participants	9 Participants n=36 Participants	32 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	0 Participants n=483 Participants	4 Participants n=36 Participants	7 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	25 Participants n=483 Participants	15 Participants n=36 Participants	47 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	4 Participants n=483 Participants	0 Participants n=36 Participants	6 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants	1 Participants n=36 Participants	2 Participants n=10 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants	20 Participants n=483 Participants	18 Participants n=36 Participants	46 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants
Region of Enrollment United States	3 participants n=93 Participants	3 participants n=4 Participants	4 participants n=27 Participants	25 participants n=483 Participants	19 participants n=36 Participants	54 participants n=10 Participants

PRIMARY outcome

Timeframe: Up to Week 24 for Dose Escalation subjects; up to Week 28 for Second Phase subjects; up to 9 Months for Third Phase subjects.

Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.

Outcome measures

Measure	Dose Escalation: NanoPac® 6 mg/mL n=3 Participants Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 10 mg/mL n=3 Participants Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 15 mg/mL n=4 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Second Phase: NanoPac® 15 mg/mL n=25 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive two NanoPac® administrations, with the second injection administered one month after the first injection.	Third Phase: NanoPac® 15 mg/mL n=19 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive up to four NanoPac® administrations, with injections administered one month apart.
Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability) Number of subjects with at least one TEAE	3 Participants	3 Participants	4 Participants	23 Participants	19 Participants
Number of Subjects With Treatment Emergent Adverse Events (Safety and Tolerability) Number of subjects without any TEAE	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 24

Response was determined using RECIST 1.1 parameters (complete response, partial response, stable disease, progressive disease, unevaluable) for the treated lesion in all groups.

Outcome measures

Measure	Dose Escalation: NanoPac® 6 mg/mL n=3 Participants Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 10 mg/mL n=3 Participants Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 15 mg/mL n=4 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Second Phase: NanoPac® 15 mg/mL n=25 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive two NanoPac® administrations, with the second injection administered one month after the first injection.	Third Phase: NanoPac® 15 mg/mL n=19 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive up to four NanoPac® administrations, with injections administered one month apart.
Target Tumor Assessment Complete Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Target Tumor Assessment Partial Response	0 Participants	1 Participants	0 Participants	2 Participants	3 Participants
Target Tumor Assessment Stable Disease	1 Participants	0 Participants	1 Participants	12 Participants	2 Participants
Target Tumor Assessment Progressive Disease	1 Participants	2 Participants	0 Participants	1 Participants	5 Participants
Target Tumor Assessment Not evaluable	1 Participants	0 Participants	3 Participants	10 Participants	9 Participants

SECONDARY outcome

Timeframe: Day 1 and Week 24

Population: Not all subjects had data at all timepoints. On Day 1, data available for one subject in dose escalation 6 mg/mL, none in 10 mg/mL, and one in 15 mg/mL; second phase, six subjects; third phase three subjects. At Week 24, data available for one subject in dose escalation 6 mg/mL, none in 10 mg/mL, none in 15 mg/mL; second phase, eight subjects; third phase five subjects. Forty subjects received concomitant IV chemotherapy while on study; of these, 14 received concomitant taxane therapy.

Plasma paclitaxel concentrations were analyzed in the dose escalation phase on Day 1 prior to injection and at 1, 2, 4, 6, and 24 hours after NanoPac injection, as well as at all other study visits. In the second and third phases, plasma paclitaxel concentrations were analyzed on Day 1 prior to NanoPac injection, and at 1 and 2 hours post NanoPac injection on all injection occasions, and at all study visits.

Outcome measures

Measure	Dose Escalation: NanoPac® 6 mg/mL n=2 Participants Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 10 mg/mL Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 15 mg/mL n=1 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Second Phase: NanoPac® 15 mg/mL n=11 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive two NanoPac® administrations, with the second injection administered one month after the first injection.	Third Phase: NanoPac® 15 mg/mL n=7 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive up to four NanoPac® administrations, with injections administered one month apart.
Plasma Paclitaxel Concentration (pg/mL) Day 1 Pre-Injection	62.1 pg/mL Standard Deviation NA Only 1 subject analyzed.	—	304 pg/mL Standard Deviation NA Only 1 subject analyzed.	5497.0 pg/mL Standard Deviation 11887.04	17347.7 pg/mL Standard Deviation 27686.44
Plasma Paclitaxel Concentration (pg/mL) Week 24	30 pg/mL Standard Deviation NA Only 1 subject analyzed.	—	—	5017.8 pg/mL Standard Deviation 12139.23	63.2 pg/mL Standard Deviation 60.16

SECONDARY outcome

Timeframe: Day 1 (pre-injection) and Week 24

Population: Pain measured with VAS was not available for all subjects at all timepoints. For the Day 1 Pre-Injection timepoint, there was one subject in the 6 mg/mL dose escalation group for whom VAS was not available. For the Week 24 timepoint, there was one subject in the 6 mg/mL dose escalation group, three in the 15 mg/mL dose escalation group, 12 in the second phase, and 9 in the third phase for whom VAS data was not available.

The visual analog scale (VAS) ranks pain from numbers 0 (no pain) to 10 (most pain). Lower scores mean a better outcome.

Outcome measures

Measure	Dose Escalation: NanoPac® 6 mg/mL n=2 Participants Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 10 mg/mL n=3 Participants Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 15 mg/mL n=4 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Second Phase: NanoPac® 15 mg/mL n=25 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive two NanoPac® administrations, with the second injection administered one month after the first injection.	Third Phase: NanoPac® 15 mg/mL n=19 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive up to four NanoPac® administrations, with injections administered one month apart.
Pain (Visual Analog Scale) Score Day 1 (Pre-Injection)	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0	5.5 units on a scale Standard Deviation 4.12	1.2 units on a scale Standard Deviation 2.41	0.8 units on a scale Standard Deviation 1.42
Pain (Visual Analog Scale) Score Week 24	5.3 units on a scale Standard Deviation 3.18	0.8 units on a scale Standard Deviation 1.44	5.0 units on a scale Standard Deviation NA Data only available from one subject	1.7 units on a scale Standard Deviation 2.53	1.1 units on a scale Standard Deviation 2.23

SECONDARY outcome

Timeframe: Day 1 (Pre-Injection) and Week 24

Population: Missing CA19-9 data for Day 1: dose escalation 6 mg/mL two subjects; second phase two subjects; third phase three subjects. Missing CA19-9 data for Week 24: dose escalation 6 mg/mL one subject; dose escalation 15 mg/mL two subjects; second phase 10 subjects; third phase nine subjects.

CA19-9 is a tumor marker for pancreatic cancer. Serum CA19-9 levels were assessed at all study visits.

Outcome measures

Measure	Dose Escalation: NanoPac® 6 mg/mL n=2 Participants Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 10 mg/mL n=3 Participants Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 15 mg/mL n=4 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Second Phase: NanoPac® 15 mg/mL n=25 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive two NanoPac® administrations, with the second injection administered one month after the first injection.	Third Phase: NanoPac® 15 mg/mL n=19 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive up to four NanoPac® administrations, with injections administered one month apart.
Serum CA19-9 Level Day 1 - Pre-Injection	248 U/mL Standard Deviation NA Data available for only one subject	24 U/mL Standard Deviation 24	2958 U/mL Standard Deviation 4749	952 U/mL Standard Deviation 2171	198 U/mL Standard Deviation 362
Serum CA19-9 Level Week 24	5476 U/mL Standard Deviation 6396.49	49.3 U/mL Standard Deviation 60.3	6179 U/mL Standard Deviation 5402.3	141.6 U/mL Standard Deviation 184.03	1222.6 U/mL Standard Deviation 3126

SECONDARY outcome

Timeframe: Day 1 (Pre-Injection) and Week 24

Population: Missing CEA data for Day 1: dose escalation 6 mg/mL one subject; second phase two subjects; third phase two subjects. Missing CEA data for Week 24: dose escalation 6 mg/mL one subject; dose escalation 15 mg/mL three subjects; second phase 11 subjects; third phase nine subjects.

Carcinoembryonic antigen (CEA) is a tumor marker for pancreatic cancer.

Outcome measures

Measure	Dose Escalation: NanoPac® 6 mg/mL n=2 Participants Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 10 mg/mL n=3 Participants Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 15 mg/mL n=4 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Second Phase: NanoPac® 15 mg/mL n=25 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive two NanoPac® administrations, with the second injection administered one month after the first injection.	Third Phase: NanoPac® 15 mg/mL n=19 Participants Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects receive up to four NanoPac® administrations, with injections administered one month apart.
Serum CEA Levels Day 1 - Pre-Injection	1.65 ug/L Standard Deviation 0.778	27.1 ug/L Standard Deviation 41.57	4.58 ug/L Standard Deviation 1.68	5.17 ug/L Standard Deviation 3.163	6.69 ug/L Standard Deviation 5.976
Serum CEA Levels Week 24	4.55 ug/L Standard Deviation 2.758	53.33 ug/L Standard Deviation 84.577	10.3 ug/L Standard Deviation NA Data available only for one subject	5.49 ug/L Standard Deviation 3.291	13.04 ug/L Standard Deviation 16.718

Adverse Events

Dose Escalation: NanoPac® 6 mg/mL

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Escalation: NanoPac® 10 mg/mL

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Dose Escalation: NanoPac® 15 mg/mL

Serious events: 3 serious events

Other events: 4 other events

Deaths: 1 deaths

Second Phase: NanoPac® 15 mg/mL

Serious events: 13 serious events

Other events: 23 other events

Deaths: 1 deaths

Third Phase: NanoPac® 15 mg/mL

Serious events: 8 serious events

Other events: 19 other events

Deaths: 3 deaths

Serious adverse events

Measure	Dose Escalation: NanoPac® 6 mg/mL n=3 participants at risk Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 10 mg/mL n=3 participants at risk Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 15 mg/mL n=4 participants at risk Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Second Phase: NanoPac® 15 mg/mL n=25 participants at risk Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received two NanoPac® administrations, with the second injection administered one month after the first injection.	Third Phase: NanoPac® 15 mg/mL n=19 participants at risk Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received up to four NanoPac® administrations, with injections administered one month apart.
Cardiac disorders Arrhythmia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Abdominal Pain	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	50.0% 2/4 • Number of events 4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	8.0% 2/25 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Colitis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Duodenal obstruction	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Obstruction gastric	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
General disorders Disease progression	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
General disorders Pyrexia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Hepatobiliary disorders Bile duct obstruction	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Hepatobiliary disorders Cholangitis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Hepatobiliary disorders Cholangitis acute	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Infections and infestations Abdominal abscess	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Infections and infestations Biliary tract infection	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	8.0% 2/25 • Number of events 3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Infections and infestations Sepsis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	12.0% 3/25 • Number of events 4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Metabolism and nutrition disorders Acidosis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Product Issues Device occlusion	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Renal and urinary disorders Haematuria	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Renal and urinary disorders Urinary retention	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Vascular disorders Embolism	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.

Other adverse events

Measure	Dose Escalation: NanoPac® 6 mg/mL n=3 participants at risk Intratumorally injected NanoPac® 6 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 10 mg/mL n=3 participants at risk Intratumorally injected NanoPac® 10 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Dose Escalation: NanoPac® 15 mg/mL n=4 participants at risk Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection.	Second Phase: NanoPac® 15 mg/mL n=25 participants at risk Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received two NanoPac® administrations, with the second injection administered one month after the first injection.	Third Phase: NanoPac® 15 mg/mL n=19 participants at risk Intratumorally injected NanoPac® 15 mg/mL at a volume of up to 20% tumor volume via endoscopic ultrasound-guided direct injection. Subjects received up to four NanoPac® administrations, with injections administered one month apart.
Investigations Platelet count decreased	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	12.0% 3/25 • Number of events 3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Investigations Urine analysis abnormal	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Investigations Weight decreased	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	24.0% 6/25 • Number of events 7 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	15.8% 3/19 • Number of events 4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	15.8% 3/19 • Number of events 4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Blood and lymphatic system disorders Retroperitoneal lymphadenopathy	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Cardiac disorders Bradycardia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Cardiac disorders Pericardial effusion	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Cardiac disorders Tachycardia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Eye disorders Dry eye	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Abdominal distension	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	16.0% 4/25 • Number of events 5 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Abdominal pain	66.7% 2/3 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	75.0% 3/4 • Number of events 3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	40.0% 10/25 • Number of events 16 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	31.6% 6/19 • Number of events 7 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Abdominal pain upper	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	16.0% 4/25 • Number of events 4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Abdominal tenderness	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Ascites	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	12.0% 3/25 • Number of events 3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Colitis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Constipation	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	20.0% 5/25 • Number of events 5 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	15.8% 3/19 • Number of events 3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	20.0% 5/25 • Number of events 6 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Duodenal stenosis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	8.0% 2/25 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Flatulence	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	8.0% 2/25 • Number of events 3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Gastritis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Gastrointestinal motility disorder	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Haematochezia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	12.0% 3/25 • Number of events 3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Large intestine polyp	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Melaena	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	66.7% 2/3 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	28.0% 7/25 • Number of events 8 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	15.8% 3/19 • Number of events 4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	20.0% 5/25 • Number of events 8 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
General disorders Asthenia	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
General disorders Chills	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
General disorders Discomfort	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
General disorders Face oedema	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
General disorders Fatigue	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	36.0% 9/25 • Number of events 9 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	31.6% 6/19 • Number of events 11 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
General disorders Malaise	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
General disorders Mucosal inflammation	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
General disorders Oedema	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
General disorders Oedema peripheral	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	8.0% 2/25 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
General disorders Pain	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
General disorders Pyrexia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Hepatobiliary disorders Bile duct stenosis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Hepatobiliary disorders Bile duct stone	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Hepatobiliary disorders Hepatic lesion	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Hepatobiliary disorders Hepatomegaly	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Hepatobiliary disorders Jaundice	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Infections and infestations Candida infection	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Infections and infestations Clostridium difficile infection	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Infections and infestations Corona virus infection	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Infections and infestations Eye infection	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Infections and infestations Lung infection	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Infections and infestations Medical device site cellulitis	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Infections and infestations Sepsis	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	8.0% 2/25 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Infections and infestations Urinary tract infection	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Injury, poisoning and procedural complications Animal bite	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Injury, poisoning and procedural complications Chest injury	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Investigations Blood bilirubin increased	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Investigations Full blood count abnormal	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Investigations Liver function test increased	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	15.8% 3/19 • Number of events 3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Investigations Neutrophil count decreased	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Investigations Pancreatic enzymes decreased	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	8.0% 2/25 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Investigations White blood cell count decreased	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Investigations White blood cell count increased	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Metabolism and nutrition disorders Cachexia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	8.0% 2/25 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	12.0% 3/25 • Number of events 3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	15.8% 3/19 • Number of events 4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Metabolism and nutrition disorders Diabetes mellitus	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	26.3% 5/19 • Number of events 7 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	8.0% 2/25 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Metabolism and nutrition disorders Malnutrition	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Musculoskeletal and connective tissue disorders Muscle twitching	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Musculoskeletal and connective tissue disorders Senile osteoporosis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Nervous system disorders Dizziness	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	15.8% 3/19 • Number of events 4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Nervous system disorders Dysgeusia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Nervous system disorders Encephalopathy	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Nervous system disorders Haemorrhage intracranial	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Nervous system disorders Hypersomnia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Nervous system disorders Neuropathy peripheral	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	8.0% 2/25 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	26.3% 5/19 • Number of events 5 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Nervous system disorders Paraesthesia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Nervous system disorders Syncope	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Product Issues Device occlusion	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Psychiatric disorders Anxiety	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Psychiatric disorders Insomnia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Renal and urinary disorders Bladder trabeculation	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Renal and urinary disorders Choluria	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Renal and urinary disorders Urinary retention	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Reproductive system and breast disorders Genital rash	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Reproductive system and breast disorders Pelvic pain	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Respiratory, thoracic and mediastinal disorders Bronchostenosis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	25.0% 1/4 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Skin and subcutaneous tissue disorders Pruritus generalised	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Surgical and medical procedures Antiviral prophylaxis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Vascular disorders Haematoma	33.3% 1/3 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Vascular disorders Hypertension	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	4.0% 1/25 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/19 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Vascular disorders Hypotension	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	8.0% 2/25 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	10.5% 2/19 • Number of events 2 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.
Vascular disorders Peripheral coldness	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/3 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/4 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	0.00% 0/25 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.	5.3% 1/19 • Number of events 1 • Up to 9 months AEs were collected at all study visits from the time of dosing. Subjects were required to spontaneously report any AE. Study personnel asked open-ended questions to obtain information about AEs at every visit. Total AEs are reported in this record regardless of relationship to study treatment.

Additional Information

Mark Mitchell

NanOlogy, LLC

Phone: 8179004074

Email: Mark.Mitchell@dfb.com

Results disclosure agreements

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