Trial Outcomes & Findings for A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations (NCT NCT03000348)

NCT ID: NCT03000348

Last Updated: 2021-04-14

Results Overview

Change from baseline through to Day 21 in log10 cfu/ml transformed total gram negative sputum bacterial load

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 91 participants
• Primary outcome timeframe: Baseline through Day 21/End of Study
• Results posted on: 2021-04-14

Participant Flow

91 adult CF patients experiencing a pulmonary exacerbation were enrolled across 15 US and EU centres. 89 patients were randomised and 78 completed the 14 day treatment period of the study. First Patient first visit was 12 Jan 2017 and Last Patient last visit was 11 April 2018.

Of the 91 patients enrolled 89 patients met the inclusion criteria and 2 were not eligible: 1 patient had <4 Fuchs criteria (not considered to be exacerbating) 1 patient had reproductive issues

Participant milestones

Measure	Placebo Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Three Times Per Day Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Overall Study STARTED	17	11	15	15	16	15
Overall Study Day 14 Treatment Period	17	10	13	14	13	14
Overall Study COMPLETED	14	7	11	12	11	13
Overall Study NOT COMPLETED	3	4	4	3	5	2

Reasons for withdrawal

Measure	Placebo Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Three Times Per Day Patient takes three oral doses of Cysteamine (450mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Overall Study Adverse Event	1	1	1	1	1	1
Overall Study Lost to Follow-up	0	0	1	0	0	0
Overall Study Withdrawal by Subject	0	1	0	0	0	0
Overall Study Consent	0	0	0	0	1	0
Overall Study Failure to expectorate sputum	1	0	1	0	1	0
Overall Study No gram negative	1	2	1	1	1	1
Overall Study Patient had no transport	0	0	0	1	0	0
Overall Study Dosing	0	0	0	0	1	0

Baseline Characteristics

A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations

Baseline characteristics by cohort

Measure	Placebo n=17 Participants Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day n=11 Participants Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day n=15 Participants Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day n=16 Participants Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule	Total n=89 Participants Total of all reporting groups
Age, Continuous	27.2 years STANDARD_DEVIATION 5.64 • n=5 Participants	27.5 years STANDARD_DEVIATION 6.77 • n=7 Participants	32.5 years STANDARD_DEVIATION 12.7 • n=5 Participants	32.3 years STANDARD_DEVIATION 9.78 • n=4 Participants	31.4 years STANDARD_DEVIATION 12.0 • n=21 Participants	27.5 years STANDARD_DEVIATION 7.89 • n=8 Participants	29.8 years STANDARD_DEVIATION 9.59 • n=8 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	8 Participants n=8 Participants	43 Participants n=8 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants	7 Participants n=4 Participants	8 Participants n=21 Participants	7 Participants n=8 Participants	46 Participants n=8 Participants
Ethnicity (NIH/OMB) 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	1 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	12 Participants n=4 Participants	15 Participants n=21 Participants	13 Participants n=8 Participants	78 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	10 Participants n=8 Participants
BMI	20.2 kg/m^2 STANDARD_DEVIATION 2.23 • n=5 Participants	20.3 kg/m^2 STANDARD_DEVIATION 3.03 • n=7 Participants	20.7 kg/m^2 STANDARD_DEVIATION 2.41 • n=5 Participants	21.5 kg/m^2 STANDARD_DEVIATION 2.21 • n=4 Participants	20.5 kg/m^2 STANDARD_DEVIATION 3.03 • n=21 Participants	21.7 kg/m^2 STANDARD_DEVIATION 2.84 • n=8 Participants	20.8 kg/m^2 STANDARD_DEVIATION 2.61 • n=8 Participants
Age at CF Diagnosis	0.9 years STANDARD_DEVIATION 2.41 • n=5 Participants	3.9 years STANDARD_DEVIATION 0.24 • n=7 Participants	0.3 years STANDARD_DEVIATION 0.49 • n=5 Participants	1.6 years STANDARD_DEVIATION 4.93 • n=4 Participants	4.8 years STANDARD_DEVIATION 11.45 • n=21 Participants	1.8 years STANDARD_DEVIATION 5.63 • n=8 Participants	0.9 years STANDARD_DEVIATION 2.41 • n=8 Participants
Duration of CF years	26.36 years STANDARD_DEVIATION 5.69 • n=5 Participants	23.7 years STANDARD_DEVIATION 9.26 • n=7 Participants	32.45 years STANDARD_DEVIATION 12.44 • n=5 Participants	31.11 years STANDARD_DEVIATION 10.92 • n=4 Participants	26.76 years STANDARD_DEVIATION 11.69 • n=21 Participants	25.88 years STANDARD_DEVIATION 7.07 • n=8 Participants	27.85 years STANDARD_DEVIATION 9.97 • n=8 Participants
FEV1 Percent predicted (%)	41.5 litres per second STANDARD_DEVIATION 15.31 • n=5 Participants	39.4 litres per second STANDARD_DEVIATION 19.81 • n=7 Participants	48.0 litres per second STANDARD_DEVIATION 18.26 • n=5 Participants	46.1 litres per second STANDARD_DEVIATION 22.75 • n=4 Participants	37.7 litres per second STANDARD_DEVIATION 13.44 • n=21 Participants	46.9 litres per second STANDARD_DEVIATION 20.58 • n=8 Participants	43.3 litres per second STANDARD_DEVIATION 18.34 • n=8 Participants

PRIMARY outcome

Timeframe: Baseline through Day 21/End of Study

Population: Intention to treat population

Change from baseline through to Day 21 in log10 cfu/ml transformed total gram negative sputum bacterial load

Outcome measures

Measure	Placebo n=17 Participants Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day n=11 Participants Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day n=15 Participants Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day n=16 Participants Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Change From Baseline in Sputum Bacterial Load Day 7 change from baseline	-2.1 log 10 cfu/ml Standard Deviation 2.887	-1.03 log 10 cfu/ml Standard Deviation 3.124	-1.28 log 10 cfu/ml Standard Deviation 1.978	-1.7 log 10 cfu/ml Standard Deviation 2.439	-1.03 log 10 cfu/ml Standard Deviation 1.997	-0.25 log 10 cfu/ml Standard Deviation 2.228
Change From Baseline in Sputum Bacterial Load Day 14 change from baseline	-1.38 log 10 cfu/ml Standard Deviation 2.291	0.12 log 10 cfu/ml Standard Deviation 2.045	-1.24 log 10 cfu/ml Standard Deviation 2.686	-1.32 log 10 cfu/ml Standard Deviation 2.298	-0.98 log 10 cfu/ml Standard Deviation 1.894	0.33 log 10 cfu/ml Standard Deviation 2.270
Change From Baseline in Sputum Bacterial Load Day 21 change from baseline	-0.18 log 10 cfu/ml Standard Deviation 1.238	-1.22 log 10 cfu/ml Standard Deviation 2.760	-0.26 log 10 cfu/ml Standard Deviation 1.639	-1.04 log 10 cfu/ml Standard Deviation 2.891	-0.87 log 10 cfu/ml Standard Deviation 1.677	0.93 log 10 cfu/ml Standard Deviation 2.348

PRIMARY outcome

Timeframe: Baseline through Day 21/End of Study

Population: Summary of participant reported adverse events (AEs) by study group

Assessed by variables such as adverse events (AEs), laboratory assessments, physical examinations, and vital signs.

Outcome measures

Measure	Placebo n=17 Participants Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day n=11 Participants Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day n=15 Participants Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day n=16 Participants Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events Number of AEs	30 participants	29 participants	40 participants	33 participants	45 participants	36 participants
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events Number of SAEs	1 participants	1 participants	2 participants	1 participants	0 participants	1 participants
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events 1 or more AEs	9 participants	10 participants	11 participants	12 participants	10 participants	13 participants
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events Severity of AE mild	7 participants	6 participants	5 participants	6 participants	4 participants	7 participants
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events Severity of AE moderate	2 participants	4 participants	6 participants	5 participants	5 participants	6 participants
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events Severity of AE severe	0 participants	0 participants	0 participants	1 participants	1 participants	0 participants
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events AEs leading to drug discontinuation	1 participants	1 participants	1 participants	1 participants	1 participants	1 participants
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events Nausea	0 participants	3 participants	5 participants	3 participants	5 participants	3 participants
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events Vomiting	0 participants	2 participants	2 participants	2 participants	2 participants	1 participants
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events Insomnia	0 participants	0 participants	2 participants	0 participants	1 participants	2 participants
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events Rash	0 participants	0 participants	1 participants	1 participants	3 participants	0 participants
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events Arthralgia	0 participants	1 participants	1 participants	1 participants	0 participants	1 participants
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events Decreased appetite	0 participants	0 participants	1 participants	0 participants	2 participants	1 participants
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events Haemoptysis	2 participants	0 participants	1 participants	1 participants	2 participants	0 participants
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events Oropharyngeal pain	0 participants	1 participants	1 participants	0 participants	1 participants	1 participants
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events Abdominal pain	1 participants	0 participants	1 participants	0 participants	2 participants	0 participants
Safety and Tolerability Assessed by the Number of Subjects With Adverse Events Breath odour	0 participants	0 participants	0 participants	1 participants	0 participants	2 participants

SECONDARY outcome

Timeframe: Baseline through Day 21/End of Study

Population: Neutrophil Elastase Levels by Visit - Covariate Adjusted ANCOVA with Observed Data ITT Population

Actual values and change from baseline in neutrophil elastase levels were summarized using descriptive statistics by visit for each treatment group and each TDD group for the ITT Population.

Outcome measures

Measure	Placebo n=17 Participants Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day n=11 Participants Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day n=15 Participants Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day n=16 Participants Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Change From Baseline in Neutrophil Elastase Levels Day 7 change from baseline	-4659 ng/mL Standard Deviation 38335	23431 ng/mL Standard Deviation 53111	704 ng/mL Standard Deviation 36395	-19623 ng/mL Standard Deviation 35548	-15769 ng/mL Standard Deviation 40899	5135 ng/mL Standard Deviation 27791
Change From Baseline in Neutrophil Elastase Levels Day 14 change from baseline	-3706 ng/mL Standard Deviation 42879	-380 ng/mL Standard Deviation 157122	-7208 ng/mL Standard Deviation 19210	-12014 ng/mL Standard Deviation 23269	-14083 ng/mL Standard Deviation 41215	14660 ng/mL Standard Deviation 35539
Change From Baseline in Neutrophil Elastase Levels Day 21 change from baseline	-1000 ng/mL Standard Deviation 59856	4853 ng/mL Standard Deviation 18616	171 ng/mL Standard Deviation 19229	-21002 ng/mL Standard Deviation 2472	-14591 ng/mL Standard Deviation 39179	-2558 ng/mL Standard Deviation 20068

SECONDARY outcome

Timeframe: Baseline through Day 21/End of Study

Population: ITT Population

Sputum IL-8 Levels by Visit - Covariate Adjusted ANCOVA with Observed Data ITT Population

Outcome measures

Measure	Placebo n=17 Participants Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day n=11 Participants Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day n=15 Participants Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day n=16 Participants Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Change From Baseline in Sputum IL8 Day 7 change from baseline	-26088 pg/mL Standard Deviation 55506	-17864 pg/mL Standard Deviation 33785	-5511 pg/mL Standard Deviation 46204	111574 pg/mL Standard Deviation 70338	-2663 pg/mL Standard Deviation 41802	-25785 pg/mL Standard Deviation 53721
Change From Baseline in Sputum IL8 Day 14 Change from baseline	-28856 pg/mL Standard Deviation 39456	-26528 pg/mL Standard Deviation 46737	-33653 pg/mL Standard Deviation 55302	3167 pg/mL Standard Deviation 28204	-6136 pg/mL Standard Deviation 53611	221 pg/mL Standard Deviation 30639
Change From Baseline in Sputum IL8 Day 21 change from baseline	9576 pg/mL Standard Deviation 66157	-16043 pg/mL Standard Deviation 34551	-19778 pg/mL Standard Deviation 49306	2831 pg/mL Standard Deviation 23050	631 pg/mL Standard Deviation 32350	-10671 pg/mL Standard Deviation 65656

SECONDARY outcome

Timeframe: Baseline through Day 21/End of Study

Population: Change from Baseline in FEV1 Percent Predicted (%) - Covariate Adjusted ANCOVA with Observed Data ITT Population

Change from Baseline in FEV1 Percent Predicted (%) - Covariate Adjusted ANCOVA with Observed Data ITT Population

Outcome measures

Measure	Placebo n=17 Participants Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day n=11 Participants Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day n=15 Participants Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day n=16 Participants Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Change From Baseline in FEV1 Day 7 change from baseline	7.9 percentage of predicted Standard Deviation 13.67	4.4 percentage of predicted Standard Deviation 5.52	6.9 percentage of predicted Standard Deviation 8.85	11.8 percentage of predicted Standard Deviation 9.96	4.9 percentage of predicted Standard Deviation 5.48	3.7 percentage of predicted Standard Deviation 8.65
Change From Baseline in FEV1 Day 14 change from baseline	9.2 percentage of predicted Standard Deviation 14.03	4.0 percentage of predicted Standard Deviation 5.14	8.9 percentage of predicted Standard Deviation 10.87	13.6 percentage of predicted Standard Deviation 10.83	5.3 percentage of predicted Standard Deviation 6.65	7.5 percentage of predicted Standard Deviation 7.07
Change From Baseline in FEV1 Day 21 change from baseline	9.5 percentage of predicted Standard Deviation 13.5	4.7 percentage of predicted Standard Deviation 5.03	6.5 percentage of predicted Standard Deviation 7.25	8.9 percentage of predicted Standard Deviation 10.66	6.4 percentage of predicted Standard Deviation 8.18	6.3 percentage of predicted Standard Deviation 11.34

SECONDARY outcome

Timeframe: Baseline through Day 21/End of Study

Population: ITT

BMI (kg/m^2) by Visit - ANCOVA with Observed Data ITT Population

Outcome measures

Measure	Placebo n=17 Participants Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day n=11 Participants Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day n=15 Participants Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day n=16 Participants Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Change From Baseline in BMI BMI Day 7 change from baseline	0.39 kg/m^2 for BMI Standard Deviation 0.371	0.32 kg/m^2 for BMI Standard Deviation 0.498	0.28 kg/m^2 for BMI Standard Deviation 0.3	0.24 kg/m^2 for BMI Standard Deviation 0.428	0.15 kg/m^2 for BMI Standard Deviation 0.586	0.15 kg/m^2 for BMI Standard Deviation 0.589
Change From Baseline in BMI BMI Day 14 change from baseline	0.34 kg/m^2 for BMI Standard Deviation 0.452	0.64 kg/m^2 for BMI Standard Deviation 0.505	0.34 kg/m^2 for BMI Standard Deviation 0.477	0.37 kg/m^2 for BMI Standard Deviation 0.488	0.23 kg/m^2 for BMI Standard Deviation 0.705	0.32 kg/m^2 for BMI Standard Deviation 0.893
Change From Baseline in BMI BMI Day 21 change from baseline	0.54 kg/m^2 for BMI Standard Deviation 0.537	0.55 kg/m^2 for BMI Standard Deviation 0.553	0.47 kg/m^2 for BMI Standard Deviation 0.564	0.18 kg/m^2 for BMI Standard Deviation 0.478	-0.02 kg/m^2 for BMI Standard Deviation 0.980	0.12 kg/m^2 for BMI Standard Deviation 0.828

SECONDARY outcome

Timeframe: Baseline through Day 21

Population: CRP by visit ANCOVA with observed data ITT population

Change from baseline in C-Reactive Protein at visits 7, 14 and 21

Outcome measures

Measure	Placebo n=17 Participants Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day n=11 Participants Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day n=15 Participants Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day n=16 Participants Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Change From Baseline in C-Reactive Protein Day 7 change from baseline	-182.828 nmol/L Standard Deviation 188.1222	-285.006 nmol/L Standard Deviation 295.0114	-229.821 nmol/L Standard Deviation 590.1267	-318.933 nmol/L Standard Deviation 344.9138	-120.193 nmol/L Standard Deviation 200.2307	-281.752 nmol/L Standard Deviation 293.2595
Change From Baseline in C-Reactive Protein Day 14 change from baseline	-75.671 nmol/L Standard Deviation 331.2220	-312.435 nmol/L Standard Deviation 323.8782	-216.105 nmol/L Standard Deviation 617.1174	-215.242 nmol/L Standard Deviation 225.7293	-111.272 nmol/L Standard Deviation 124.8394	-294.13 nmol/L Standard Deviation 509.9255
Change From Baseline in C-Reactive Protein Day 21 change from baseline	-44.341 nmol/L Standard Deviation 296.4493	-237.062 nmol/L Standard Deviation 378.4493	-116.442 nmol/L Standard Deviation 730.9709	-198.759 nmol/L Standard Deviation 235.0256	-23.421 nmol/L Standard Deviation 157.4203	-225.787 nmol/L Standard Deviation 543.1070

SECONDARY outcome

Timeframe: Baseline through Day 21/End of Study

Population: ITT

Blood Leukocyte Count (10^9 leucocytes/L) by Visit - ANCOVA with Observed Data ITT Population

Outcome measures

Measure	Placebo n=17 Participants Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day n=11 Participants Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day n=15 Participants Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day n=16 Participants Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Change From Baseline in Blood Leukocyte Count Day 7 change from baseline	-2.553 10^9 leucocytes/L Standard Deviation 4.617	-1.836 10^9 leucocytes/L Standard Deviation 2.0566	-2.808 10^9 leucocytes/L Standard Deviation 3.595	-2.482 10^9 leucocytes/L Standard Deviation 3.4502	-2.575 10^9 leucocytes/L Standard Deviation 3.1189	-2.863 10^9 leucocytes/L Standard Deviation 2.9932
Change From Baseline in Blood Leukocyte Count Day 14 change from baseline	-1.568 10^9 leucocytes/L Standard Deviation 4.7176	-2.220 10^9 leucocytes/L Standard Deviation 2.3451	-2.648 10^9 leucocytes/L Standard Deviation 3.9122	-3.419 10^9 leucocytes/L Standard Deviation 3.5734	-0.193 10^9 leucocytes/L Standard Deviation 3.8376	-4.066 10^9 leucocytes/L Standard Deviation 2.4102
Change From Baseline in Blood Leukocyte Count Day 21 change from baseline	-1.870 10^9 leucocytes/L Standard Deviation 4.6187	-1.757 10^9 leucocytes/L Standard Deviation 2.6670	-1.880 10^9 leucocytes/L Standard Deviation 3.0935	-1.763 10^9 leucocytes/L Standard Deviation 3.3193	-0.127 10^9 leucocytes/L Standard Deviation 2.5869	-3.316 10^9 leucocytes/L Standard Deviation 3.6322

SECONDARY outcome

Timeframe: Day 14

Population: Safety population

Study Drug Plasma at Day 14 Safety Population

Outcome measures

Measure	Placebo n=15 Participants Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day n=10 Participants Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day n=13 Participants Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day n=14 Participants Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day n=12 Participants Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Three Times Per Day n=14 Participants Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Assessment of Blood Cysteamine Levels	10.0 ng/ml Standard Deviation 0.00	515.11 ng/ml Standard Deviation 683.956	102.45 ng/ml Standard Deviation 144.863	347.76 ng/ml Standard Deviation 507.747	256.85 ng/ml Standard Deviation 377.262	256.84 ng/ml Standard Deviation 251.593

SECONDARY outcome

Timeframe: Day 14

Population: Safety Population - there are fewer numbers of patients due to the inability of some patients to provide sputum samples

Study Drug Sputum Concentrations at Day 14 Safety Population

Outcome measures

Measure	Placebo n=15 Participants Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day n=9 Participants Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day n=10 Participants Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day n=10 Participants Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day n=12 Participants Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Three Times Per Day n=14 Participants Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Assessment of Sputum Cysteamine Levels	150.0 ng/ml Standard Deviation 0.00	682.8 ng/ml Standard Deviation 1009.8	150.0 ng/ml Standard Deviation 0.0	316.4 ng/ml Standard Deviation 1423.6	739.7 ng/ml Standard Deviation 1423.6	811.1 ng/ml Standard Deviation 917.49

SECONDARY outcome

Timeframe: Baseline through to Day 21

Population: Mean Change from Baseline in CRFSD-CRISS - Linear MMRM Model with Observed Data (ITT Population)

Mean Change from Baseline in Cystic Fibrosis Respiratory Symptom Diary (CFRSD)-Chronic Respiratory Infection Symptom Scale (CRISS) CRFSD-CRISS:The CFRSD is a 16-item PROM to evaluate the effect of treatment on the severity of symptoms of acute respiratory infections associated with CF (i.e., CFRSD-CRISS) and to assess the emotional and activity impacts of these symptoms. The overall CRISS score range is 0-100 with 100 being the most severe symptoms.The CFRSD-CRISS is a validated unidimensional scale based on a subset of 8 items from the CFRSD questionnaire that quantifies symptom severity for the previous 24 hours to capture the magnitude of symptoms in stable CF, during medically treated CF exacerbations, and during recover from an exacerbation. The 8 items on the CFRSD-CRISS were scored using a 5-point Likert scale ranging from 0 (no symptom) to 4 (the highest magnitude of severity). So score range of 0-32.

Outcome measures

Measure	Placebo n=17 Participants Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day n=11 Participants Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day n=15 Participants Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day n=16 Participants Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Change From Baseline in CFRSD-CRISS Day 7 change from baseline	-16.4 units on a scale Standard Deviation 8.31	-18.1 units on a scale Standard Deviation 10.19	-11.9 units on a scale Standard Deviation 7.98	-19.1 units on a scale Standard Deviation 10.65	-10.5 units on a scale Standard Deviation 5.91	-17.8 units on a scale Standard Deviation 12.67
Change From Baseline in CFRSD-CRISS Day 14 change from baseline	-16.3 units on a scale Standard Deviation 15.0	-24.3 units on a scale Standard Deviation 16.35	-15.5 units on a scale Standard Deviation 12.48	-28.1 units on a scale Standard Deviation 16.88	-14.8 units on a scale Standard Deviation 8.53	-23.9 units on a scale Standard Deviation 16.41
Change From Baseline in CFRSD-CRISS Day 21 change from baseline	-18.3 units on a scale Standard Deviation 11.7	-23.2 units on a scale Standard Deviation 13.36	-15.8 units on a scale Standard Deviation 11.68	-19.9 units on a scale Standard Deviation 19.23	-12.9 units on a scale Standard Deviation 6.37	22.0 units on a scale Standard Deviation 17.71

SECONDARY outcome

Timeframe: Baseline through Day 21/End of Study

Population: Change from Baseline to Day 14 in CFQ-R Respiratory Score: ANCOVA with Observed Data ITT Population

The CFQ-R is a disease-specific HRQOL (Health related quality of life) measure containing both generic and CF-specific scales and measures functioning during the previous 2 weeks. Each CFQ-R scale yielded standardized scores ranging from 0 to 100; higher scores indicated better HRQOL

Outcome measures

Measure	Placebo n=17 Participants Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day n=11 Participants Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day n=15 Participants Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day n=16 Participants Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Change From Baseline in CFQ-R Day 7 Change from baseline	14.7 units on a scale Standard Deviation 18.21	12.2 units on a scale Standard Deviation 13.81	12.0 units on a scale Standard Deviation 16.32	12.1 units on a scale Standard Deviation 14.95	15.9 units on a scale Standard Deviation 14.1	19.6 units on a scale Standard Deviation 16.11
Change From Baseline in CFQ-R Day 14 change from baseline	22.9 units on a scale Standard Deviation 21.51	24.4 units on a scale Standard Deviation 14.15	19.7 units on a scale Standard Deviation 16.76	31.3 units on a scale Standard Deviation 17.38	21.8 units on a scale Standard Deviation 14.07	28.6 units on a scale Standard Deviation 15.69
Change From Baseline in CFQ-R Day 21 change from baseline	24.3 units on a scale Standard Deviation 19.34	30.6 units on a scale Standard Deviation 17.62	25.2 units on a scale Standard Deviation 19.19	31.3 units on a scale Standard Deviation 30.08	24.8 units on a scale Standard Deviation 14.85	37.3 units on a scale Standard Deviation 23.61

SECONDARY outcome

Timeframe: changes from baseline at day 7 and day 14

Population: ITT Linear MMRM Model with Observed Data

The Jarad and Sequeiros Symptom Questionnaire (Jarad, 2012) is a simple participant-completed questionnaire that assesses and evaluates change in participant symptoms related to different aspects of respiratory function during a CF exacerbation. The questionnaire consists of 4 questions, each answered on a 4-point scale ranging from 1 (best) to 4 (worst). A range of minimum 4 to maximum16.Jarad and Sequeiros Questionnaire Score - changes from baseline at day 7 and day 14

Outcome measures

Measure	Placebo n=17 Participants Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day n=11 Participants Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day n=15 Participants Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day n=16 Participants Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Change From Baseline in Jarad and Sequeiros Symptom Score Questionnaire change from baseline to day 7	-2.6 units on a scale Standard Deviation 1.97	-1.9 units on a scale Standard Deviation 2.38	-1.4 units on a scale Standard Deviation 1.85	-3.3 units on a scale Standard Deviation 2.35	-2.4 units on a scale Standard Deviation 2.21	-3.1 units on a scale Standard Deviation 3.33
Change From Baseline in Jarad and Sequeiros Symptom Score Questionnaire change from baseline to day 14	-3.2 units on a scale Standard Deviation 2.9	-2.9 units on a scale Standard Deviation 2.6	-2.0 units on a scale Standard Deviation 2.48	-4.3 units on a scale Standard Deviation 2.16	-3.1 units on a scale Standard Deviation 2.63	-4.2 units on a scale Standard Deviation 3.19

SECONDARY outcome

Timeframe: Baseline through Day 21/End of Study

Population: ITT

Weight (kg) by visit - ANCOVA with observed data

Outcome measures

Measure	Placebo n=17 Participants Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	450mg, Once Per Day n=11 Participants Patient takes one oral dose of Cysteamine (450mg) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	150mg, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (l150mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	450mg, Twice Per Day n=15 Participants Patient takes two oral doses of Cysteamine (450mg) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	300mg, Three Times Per Day n=16 Participants Patient takes three oral doses of Cysteamine (300mg) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Three Times Per Day n=15 Participants Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Change From Baseline in Weight Day 7	0.96 kg Standard Deviation 1.084	0.83 kg Standard Deviation 1.241	0.79 kg Standard Deviation 1.145	0.67 kg Standard Deviation 1.182	0.25 kg Standard Deviation 1.547	0.36 kg Standard Deviation 1.74
Change From Baseline in Weight Day 14	0.85 kg Standard Deviation 1.355	1.71 kg Standard Deviation 1.270	0.96 kg Standard Deviation 1.368	1.04 kg Standard Deviation 1.445	0.55 kg Standard Deviation 1.872	0.89 kg Standard Deviation 2.621
Change From Baseline in Weight Day 21	1.37 kg Standard Deviation 1.486	1.50 kg Standard Deviation 1.639	1.30 kg Standard Deviation 1.503	0.52 kg Standard Deviation 1.295	-0.28 kg Standard Deviation 2.728	0.34 kg Standard Deviation 2.477

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

High Dose, Once Per Day

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Low Dose, Three Times Per Day

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

High Dose, Twice Per Day

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Mid-Range Dose, Three Times Per Day

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

High Dose, Three Times Per Day

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=17 participants at risk Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Once Per Day n=11 participants at risk Patient takes one oral dose of Cysteamine (high dose) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	Low Dose, Three Times Per Day n=15 participants at risk Patient takes three oral doses of Cysteamine (low dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Twice Per Day n=15 participants at risk Patient takes two oral doses of Cysteamine (high dose) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	Mid-Range Dose, Three Times Per Day n=16 participants at risk Patient takes three oral doses of Cysteamine (mid-range dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Three Times Per Day n=15 participants at risk Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Vascular disorders Axillary vein thrombosis	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Renal and urinary disorders Nephrolithiasis	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Psychiatric disorders Depression	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Infections and infestations Infective pulmonary exacerbation of CF	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Infections and infestations Campylobacter sepsis	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.

Other adverse events

Measure	Placebo n=17 participants at risk Patient takes three oral doses of placebo, one in the morning, one at mid-day and one in the evening. Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Once Per Day n=11 participants at risk Patient takes one oral dose of Cysteamine (high dose) per day, in the morning. The patient takes two oral placebo doses, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	Low Dose, Three Times Per Day n=15 participants at risk Patient takes three oral doses of Cysteamine (low dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Twice Per Day n=15 participants at risk Patient takes two oral doses of Cysteamine (high dose) per day, one in the morning and one in the evening. The patient takes one oral placebo dose, at mid-day. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	Mid-Range Dose, Three Times Per Day n=16 participants at risk Patient takes three oral doses of Cysteamine (mid-range dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule Placebo Oral Capsule: Placebo Oral Capsule	High Dose, Three Times Per Day n=15 participants at risk Patient takes three oral doses of Cysteamine (high dose) per day, one in the morning, one at mid-day and one in the evening. Cysteamine: Oral Cysteamine Capsule
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Gastrointestinal disorders Nausea	— 0/0 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	27.3% 3/11 • Number of events 3 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	33.3% 5/15 • Number of events 5 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	20.0% 3/15 • Number of events 3 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	31.2% 5/16 • Number of events 5 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	20.0% 3/15 • Number of events 3 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Gastrointestinal disorders vomiting	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	18.2% 2/11 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	13.3% 2/15 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	13.3% 2/15 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	12.5% 2/16 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Gastrointestinal disorders Abdominal pain	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	12.5% 2/16 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Gastrointestinal disorders Diarrhoea	11.8% 2/17 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Gastrointestinal disorders Breath odour	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	13.3% 2/15 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Gastrointestinal disorders Constipation	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Gastrointestinal disorders Abdominal discomfort	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Gastrointestinal disorders Dry mouth	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Gastrointestinal disorders Dyspepsia	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Gastrointestinal disorders Gingival recession	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Gastrointestinal disorders Hypoaesthesia oral	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Gastrointestinal disorders Post-tussive vomiting	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Nervous system disorders Headache	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	45.5% 5/11 • Number of events 5 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	20.0% 3/15 • Number of events 3 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	12.5% 2/16 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Nervous system disorders Dizziness	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	18.2% 2/11 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Nervous system disorders Dysguesia	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	13.3% 2/15 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Nervous system disorders Intention tremor	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Nervous system disorders Migraine	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Nervous system disorders Sciatica	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Nervous system disorders Sinus headache	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Haemoptysis	11.8% 2/17 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	12.5% 2/16 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Sinus Pain	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Increased viscosity of bronchial secretion	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Sputum retention	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
General disorders pyrexia	11.8% 2/17 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
General disorders Fatigue	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
General disorders Oedema peripheral	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
General disorders Pain	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	13.3% 2/15 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
General disorders Administration site pain	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
General disorders Adminstration site reaction	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
General disorders Asthenia	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
General disorders Catheter site pain	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
General disorders Chest discomfort	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
General disorders Crepitations	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
General disorders Infusion site extravasation	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
General disorders Infusion site pain	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
General disorders Non-cardiac chest pain	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
General disorders Peripheral swelling	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
General disorders Sensation of foreign body	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Infections and infestations Infective pulmonary exacerbation of cystic fibrosis	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	13.3% 2/15 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Infections and infestations Urinary tract infection (bacterial)	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Infections and infestations Vulvovaginal mycotic infection	11.8% 2/17 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Infections and infestations Campylobacter sepsis	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Infections and infestations Clostridium difficle colitis	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Infections and infestations Clostridium difficle infection	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Infections and infestations Laryngitis	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Infections and infestations Oral candidiasis	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Infections and infestations Oral herpes	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Infections and infestations Pharyngitis	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Infections and infestations Tooth abcess	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Infections and infestations Viral infection	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Investigations Pulmonary function test decreased	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Investigations Alanine aminotransferase increased	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Investigations Aspartate aminotransferase increased	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Investigations Blood alkaline phosphatase increased	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Investigations C-reactive protein increased	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Investigations Carbon dioxide	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Investigations Colonoscopy	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Investigations Eosinophil count increased	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Investigations Mycobacterium tuberculosis complex test positive	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Musculoskeletal and connective tissue disorders Pain in extremity	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Skin and subcutaneous tissue disorders Rash	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	18.8% 3/16 • Number of events 3 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Musculoskeletal and connective tissue disorders Dermatitis allergic	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Skin and subcutaneous tissue disorders Pruritus allergic	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Skin and subcutaneous tissue disorders Skin odour abnormal	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	12.5% 2/16 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Psychiatric disorders Insomnia	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	13.3% 2/15 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	13.3% 2/15 • Number of events 2 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Psychiatric disorders Anxiety	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Psychiatric disorders Depression	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Vascular disorders Axillary vein thrombosis	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Vascular disorders Deep vein thrombosis	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Vascular disorders Haematoma	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Vascular disorders Hypotension	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Vascular disorders Phlebitis	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	9.1% 1/11 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Injury, poisoning and procedural complications Contusion	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Injury, poisoning and procedural complications Infusion site reaction	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.2% 1/16 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Injury, poisoning and procedural complications Stoma site reaction	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Renal and urinary disorders Nephrolithiasis	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Renal and urinary disorders Renal colic	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Ear and labyrinth disorders Hypoacusis	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Eye disorders Vision blurred	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Reproductive system and breast disorders Oligomenorrhoea	0.00% 0/17 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	6.7% 1/15 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.
Surgical and medical procedures Sinus operation	5.9% 1/17 • Number of events 1 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/11 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/16 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.	0.00% 0/15 • Adverse Events were collected from baseline (day 0, day study treatment commences) until day 21 (end of study/follow up) An AE was defined as any untoward medical occurrence in a participant in a clinical investigation who was administered a pharmaceutical product. The AE did not necessarily have a causal relationship with this product. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the investigational product.

Additional Information

Dr Deborah O'Neil, CEO

NovaBiotics Ltd

Phone: 01224 711 377

Email: deborah@novabiotics.co.uk

Results disclosure agreements

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