Trial Outcomes & Findings for Safety and Pharmacokinetic Study of Y242 in Adult Subjects (NCT NCT01515319)

NCT ID: NCT01515319

Last Updated: 2021-02-08

Results Overview

A treatment-emergent AE (TEAE) as defined as an AE that started after administration of IMP; in Part B this was an AE that started after the first dose of IMP. Adverse events with onset prior to dosing were considered as pre-treatment AEs.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 68 participants
• Primary outcome timeframe: Up to 73 days
• Results posted on: 2021-02-08

Participant Flow

Participant milestones

Measure	2mg Y242 Y242 single dose, subcutaneous (Part A)	7.5mg Y242 Y242 single dose, subcutaneous (Part A)	15mg Y242 Y242 single dose, subcutaneous (Part A)	30mg Y242 Y242 single dose, subcutaneous (Part A)	60mg Y242 Y242 single dose, subcutaneous (Part A)	90mg Y242 Y242 single dose, subcutaneous (Part A)	Placebo - Part A 0.9% saline 0.9% saline: Identical volume to that of Y242	60mg Y242 (B1) Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)	90mg Y242 (B2-B4) Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)	Placebo - Part B 0.9% saline - placebo
Overall Study STARTED	3	3	6	6	6	6	10	6	14	8
Overall Study COMPLETED	3	3	6	6	6	6	9	6	9	8
Overall Study NOT COMPLETED	0	0	0	0	0	0	1	0	5	0

Reasons for withdrawal

Measure	2mg Y242 Y242 single dose, subcutaneous (Part A)	7.5mg Y242 Y242 single dose, subcutaneous (Part A)	15mg Y242 Y242 single dose, subcutaneous (Part A)	30mg Y242 Y242 single dose, subcutaneous (Part A)	60mg Y242 Y242 single dose, subcutaneous (Part A)	90mg Y242 Y242 single dose, subcutaneous (Part A)	Placebo - Part A 0.9% saline 0.9% saline: Identical volume to that of Y242	60mg Y242 (B1) Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)	90mg Y242 (B2-B4) Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)	Placebo - Part B 0.9% saline - placebo
Overall Study Withdrawal by Subject	0	0	0	0	0	0	1	0	0	0
Overall Study Adverse Event	0	0	0	0	0	0	0	0	3	0
Overall Study Protocol Violation	0	0	0	0	0	0	0	0	2	0

Baseline Characteristics

Safety and Pharmacokinetic Study of Y242 in Adult Subjects

Baseline characteristics by cohort

Measure	2mg Y242 n=3 Participants Y242 single dose, subcutaneous (Part A)	7.5mg Y242 n=3 Participants Y242 single dose, subcutaneous (Part A)	15mg Y242 n=6 Participants Y242 single dose, subcutaneous (Part A)	30mg Y242 n=6 Participants Y242 single dose, subcutaneous (Part A)	60mg Y242 n=6 Participants Y242 single dose, subcutaneous (Part A)	90mg Y242 n=6 Participants Y242 single dose, subcutaneous (Part A)	Placebo - Part A n=10 Participants 0.9% saline 0.9% saline: Identical volume to that of Y242	60mg Y242 (B1) n=6 Participants Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)	90mg Y242 (B2-B4) n=14 Participants Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)	Placebo - Part B n=8 Participants 0.9% saline 0.9% saline: Identical volume to that of Y242	Total n=68 Participants Total of all reporting groups
Age, Continuous	30.7 years STANDARD_DEVIATION 2.52 • n=5 Participants	39.7 years STANDARD_DEVIATION 5.51 • n=7 Participants	25.5 years STANDARD_DEVIATION 5.79 • n=5 Participants	28.7 years STANDARD_DEVIATION 9.2 • n=4 Participants	31.5 years STANDARD_DEVIATION 11.47 • n=21 Participants	34.3 years STANDARD_DEVIATION 7.5 • n=8 Participants	31.3 years STANDARD_DEVIATION 6.04 • n=8 Participants	35.7 years STANDARD_DEVIATION 6.62 • n=24 Participants	29.4 years STANDARD_DEVIATION 7.1 • n=42 Participants	34.6 years STANDARD_DEVIATION 6.76 • n=42 Participants	31.6 years STANDARD_DEVIATION 7.61 • n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	10 Participants n=8 Participants	6 Participants n=24 Participants	14 Participants n=42 Participants	8 Participants n=42 Participants	68 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	7 Participants n=42 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=8 Participants	6 Participants n=8 Participants	6 Participants n=24 Participants	9 Participants n=42 Participants	7 Participants n=42 Participants	51 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants	0 Participants n=42 Participants	7 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race/Ethnicity, Customized Ethnic Origin · Hispanic Or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	4 Participants n=42 Participants
Race/Ethnicity, Customized Ethnic Origin · Not Hispanic Or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	8 Participants n=8 Participants	5 Participants n=24 Participants	14 Participants n=42 Participants	8 Participants n=42 Participants	64 Participants n=42 Participants
Region of Enrollment United Kingdom	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants	6 participants n=4 Participants	6 participants n=21 Participants	6 participants n=8 Participants	10 participants n=8 Participants	6 participants n=24 Participants	14 participants n=42 Participants	8 participants n=42 Participants	68 participants n=42 Participants
Height (cm)	183.3 cm STANDARD_DEVIATION 8.39 • n=5 Participants	174.3 cm STANDARD_DEVIATION 5.69 • n=7 Participants	177.2 cm STANDARD_DEVIATION 5.71 • n=5 Participants	180.8 cm STANDARD_DEVIATION 9.99 • n=4 Participants	177.7 cm STANDARD_DEVIATION 4.97 • n=21 Participants	179.0 cm STANDARD_DEVIATION 4.29 • n=8 Participants	176.5 cm STANDARD_DEVIATION 6.82 • n=8 Participants	174.3 cm STANDARD_DEVIATION 7.09 • n=24 Participants	179.9 cm STANDARD_DEVIATION 6.32 • n=42 Participants	180.9 cm STANDARD_DEVIATION 6.58 • n=42 Participants	178.3 cm STANDARD_DEVIATION 6.55 • n=42 Participants
Weight (kg)	87.5 kg STANDARD_DEVIATION 2.893 • n=5 Participants	80.27 kg STANDARD_DEVIATION 7.199 • n=7 Participants	84.58 kg STANDARD_DEVIATION 7.618 • n=5 Participants	83.63 kg STANDARD_DEVIATION 10.723 • n=4 Participants	82.52 kg STANDARD_DEVIATION 11.618 • n=21 Participants	83.28 kg STANDARD_DEVIATION 9.781 • n=8 Participants	81.10 kg STANDARD_DEVIATION 10.363 • n=8 Participants	76.18 kg STANDARD_DEVIATION 7.537 • n=24 Participants	84.37 kg STANDARD_DEVIATION 7.846 • n=42 Participants	89.89 kg STANDARD_DEVIATION 7.906 • n=42 Participants	83.5 kg STANDARD_DEVIATION 9.01 • n=42 Participants
BMI (kg/m^2)	26.13 kg/m^2 STANDARD_DEVIATION 1.845 • n=5 Participants	26.37 kg/m^2 STANDARD_DEVIATION 0.929 • n=7 Participants	26.88 kg/m^2 STANDARD_DEVIATION 1.148 • n=5 Participants	25.55 kg/m^2 STANDARD_DEVIATION 2.128 • n=4 Participants	26.05 kg/m^2 STANDARD_DEVIATION 2.595 • n=21 Participants	25.93 kg/m^2 STANDARD_DEVIATION 2.325 • n=8 Participants	25.94 kg/m^2 STANDARD_DEVIATION 1.731 • n=8 Participants	25.03 kg/m^2 STANDARD_DEVIATION 1.462 • n=24 Participants	26.07 kg/m^2 STANDARD_DEVIATION 1.920 • n=42 Participants	27.46 kg/m^2 STANDARD_DEVIATION 1.431 • n=42 Participants	26.2 kg/m^2 STANDARD_DEVIATION 1.84 • n=42 Participants

PRIMARY outcome

Timeframe: Up to 73 days

Population: Summary statistics included number of subjects, arithmetic mean and standard deviation.

A treatment-emergent AE (TEAE) as defined as an AE that started after administration of IMP; in Part B this was an AE that started after the first dose of IMP. Adverse events with onset prior to dosing were considered as pre-treatment AEs.

Outcome measures

Measure	2mg Y242 n=3 Participants Y242 single dose, subcutaneous (Part A)	7.5mg Y242 n=3 Participants Y242 single dose, subcutaneous (Part A)	15mg Y242 n=6 Participants Y242 single dose, subcutaneous (Part A)	30mg Y242 n=6 Participants Y242 single dose, subcutaneous (Part A)	60mg Y242 n=6 Participants Y242 single dose, subcutaneous (Part A)	90mg Y242 n=6 Participants Y242 single dose, subcutaneous (Part A)	Placebo - Part A n=10 Participants 0.9% saline 0.9% saline: Identical volume to that of Y242	60mg Y242 (B1) n=6 Participants Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)	90mg Y242 (B2-B4) n=14 Participants Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)	Placebo - Part B n=8 Participants 0.9% saline 0.9% saline: Identical volume to that of Y242
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) Total number of AEs	0 Participants	3 Participants	6 Participants	6 Participants	6 Participants	6 Participants	6 Participants	6 Participants	14 Participants	7 Participants
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) Serious TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) TEAEs leading to discontinuation	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants
Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) TEAEs leading to death	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: up to 32 day

Population: Part B - Body weight change from baseline (%) following 5 weekly doses of Y242

Summary of Time-Matched % Change from Baseline in Body Weight (Baseline = Day -1) following multiple dose of Y242 (Part B)

Outcome measures

Measure	2mg Y242 Y242 single dose, subcutaneous (Part A)	7.5mg Y242 Y242 single dose, subcutaneous (Part A)	15mg Y242 Y242 single dose, subcutaneous (Part A)	30mg Y242 Y242 single dose, subcutaneous (Part A)	60mg Y242 Y242 single dose, subcutaneous (Part A)	90mg Y242 Y242 single dose, subcutaneous (Part A)	Placebo - Part A 0.9% saline 0.9% saline: Identical volume to that of Y242	60mg Y242 (B1) n=6 Participants Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)	90mg Y242 (B2-B4) n=9 Participants Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)	Placebo - Part B n=8 Participants 0.9% saline 0.9% saline: Identical volume to that of Y242
Body Weight	—	—	—	—	—	—	—	-1.2 Percentage change in Body weight Standard Deviation 1.9	-1.0 Percentage change in Body weight Standard Deviation 1.8	1.8 Percentage change in Body weight Standard Deviation 3.4

Adverse Events

2mg Y242

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

7.5mg Y242

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

15mg Y242

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

30mg Y242

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

60mg Y242

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

90mg Y242

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo - Part A

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

60mg Y242 (B1)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

90mg Y242 (B2-B4)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo - Part B

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	2mg Y242 n=3 participants at risk Y242 single dose, subcutaneous (Part A)	7.5mg Y242 n=3 participants at risk Y242 single dose, subcutaneous (Part A)	15mg Y242 n=6 participants at risk Y242 single dose, subcutaneous (Part A)	30mg Y242 n=6 participants at risk Y242 single dose, subcutaneous (Part A)	60mg Y242 n=6 participants at risk Y242 single dose, subcutaneous (Part A)	90mg Y242 n=6 participants at risk Y242 single dose, subcutaneous (Part A)	Placebo - Part A n=10 participants at risk 0.9% saline 0.9% saline: Identical volume to that of Y242	60mg Y242 (B1) n=6 participants at risk Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)	90mg Y242 (B2-B4) n=14 participants at risk Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)	Placebo - Part B n=8 participants at risk 0.9% saline 0.9% saline: Identical volume to that of Y242
Nervous system disorders Dizziness	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	33.3% 2/6 • Number of events 2 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	14.3% 2/14 • Number of events 2 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	12.5% 1/8 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Gastrointestinal disorders Abdominal Distension	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Gastrointestinal disorders Abdominal Pain	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	33.3% 1/3 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	33.3% 2/6 • Number of events 2 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	14.3% 2/14 • Number of events 2 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Gastrointestinal disorders Dyspepsia	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Gastrointestinal disorders Nausea	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	33.3% 2/6 • Number of events 3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	83.3% 5/6 • Number of events 5 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	66.7% 4/6 • Number of events 4 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	66.7% 4/6 • Number of events 12 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	100.0% 14/14 • Number of events 39 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	12.5% 1/8 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Gastrointestinal disorders Tooth Ache	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Gastrointestinal disorders Vomiting	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	33.3% 2/6 • Number of events 2 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	28.6% 4/14 • Number of events 4 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Gastrointestinal disorders Constipation	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	7.1% 1/14 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
General disorders Feeling hot	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
General disorders Induration	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
General disorders Influenza-like Illness	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
General disorders Injection site Discolouration	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
General disorders Injection Site Induration	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	33.3% 2/6 • Number of events 2 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
General disorders Injection Site Pain	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
General disorders Injection Site Pruritus	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
General disorders Injection Site Reaction	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	100.0% 3/3 • Number of events 4 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	83.3% 5/6 • Number of events 7 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	83.3% 5/6 • Number of events 7 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	100.0% 6/6 • Number of events 6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	100.0% 6/6 • Number of events 7 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	100.0% 6/6 • Number of events 29 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	100.0% 14/14 • Number of events 58 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	12.5% 1/8 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Infections and infestations Gastoenteritis	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	7.1% 1/14 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Infections and infestations Influenza	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	7.1% 1/14 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Infections and infestations Nasopharyngitis	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	20.0% 2/10 • Number of events 2 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	14.3% 2/14 • Number of events 2 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	25.0% 2/8 • Number of events 2 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Infections and infestations Pharyngitis	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Infections and infestations Oral Herpes	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	12.5% 1/8 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Infections and infestations Rhinitis	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	7.1% 1/14 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	12.5% 1/8 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	33.3% 1/3 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	7.1% 1/14 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	12.5% 1/8 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Injury, poisoning and procedural complications Laceration	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	12.5% 1/8 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Injury, poisoning and procedural complications Muscle injury	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Cardiac disorders Palpitations	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	14.3% 2/14 • Number of events 2 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
General disorders Catheter Site Pain	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
General disorders Chest discomfort	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
General disorders Fatigue	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	14.3% 2/14 • Number of events 2 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	33.3% 2/6 • Number of events 2 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	7.1% 1/14 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	14.3% 2/14 • Number of events 2 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Nervous system disorders Dysgeusia	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	7.1% 1/14 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Nervous system disorders Headache	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	66.7% 4/6 • Number of events 6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	35.7% 5/14 • Number of events 10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	37.5% 3/8 • Number of events 4 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Nervous system disorders Paraesthesia	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Respiratory, thoracic and mediastinal disorders Pharyngeal Hypoaestesia	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	33.3% 1/3 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Respiratory, thoracic and mediastinal disorders Sinus Congestion	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Respiratory, thoracic and mediastinal disorders Throat Irritation	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	7.1% 1/14 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Skin and subcutaneous tissue disorders Skin Irritation	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	10.0% 1/10 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	16.7% 1/6 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/14 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	7.1% 1/14 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.
General disorders Feeling of Body temperature change	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/3 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/10 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/6 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	7.1% 1/14 • Number of events 1 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.	0.00% 0/8 • 73 days until final follow up visit The subjects were queried regularly on all study days using non-leading questions, such as "How do you feel?" In addition, all AEs reported spontaneously during the course of the study were recorded.

Additional Information

Dr Tricia Tan

Imperial College London

Phone: 020 838 38038

Email: t.tan@imperial.ac.uk

Results disclosure agreements

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