Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease (NCT NCT02151643)

NCT ID: NCT02151643

Last Updated: 2018-01-16

Results Overview

The primary efficacy endpoint was the change in serum phosphate concentration from Baseline (Visit 7, Day 1) to Visit 11 (Day 29). All study specific blood samples were collected, processed and analysed using a central laboratory.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 153 participants
• Primary outcome timeframe: Day 1 to Day 29
• Results posted on: 2018-01-16

Participant Flow

Male/female subjects with dialysis dependent CKD on prescribed maintenance haemodialysis 3 times/week for 90d before Screening were recruited and randomised to receive PT20 or placebo. Prior to Screening, all subjects were taking at least 1 OPB for a minimum of 28d mean + serum phosphate level ≥ 4.0 mg/dL and ≤ 8.0 mg/dL for the preceding 28 days.

Subjects underwent stratified randomisation into 1 of the 4 PT20 dose groups or equivalent placebo group based pre-randomisation serum phosphate level (ratio of 8:8:8:13:13) - serum phosphate < 7.5 mg/dL were deemed to have a lower level of serum phosphate; serum phosphate ≥ 7.5 mg/dL were deemed to have a higher level of serum phosphate.

Participant milestones

Measure	Group 1 - PT20 400 mg Tid PT20 400 mg tid (1.2 g/day) administered orally PT20: Modified ferric oxide adipate	Group 2 - PT20 800 mg Tid PT20 800 mg tid (2.4 g/day) administered orally PT20: Modified ferric oxide adipate	Group 3 - PT20 1600 mg Tid PT20 1600 mg tid (4.8 g/day) administered orally PT20: Modified ferric oxide adipate	Group 4 - PT20 3200 mg Tid PT20 3200 mg tid (9.6 g/day) administered orally PT20: Modified ferric oxide adipate	Group 5 - Placebo Tid Matched Placebo (for PT20) tid administered orally Placebo: Placebo tablets matched to each active PT20 dosage arm
Overall Study STARTED	26	25	25	39	38
Overall Study COMPLETED	20	21	21	32	35
Overall Study NOT COMPLETED	6	4	4	7	3

Reasons for withdrawal

Measure	Group 1 - PT20 400 mg Tid PT20 400 mg tid (1.2 g/day) administered orally PT20: Modified ferric oxide adipate	Group 2 - PT20 800 mg Tid PT20 800 mg tid (2.4 g/day) administered orally PT20: Modified ferric oxide adipate	Group 3 - PT20 1600 mg Tid PT20 1600 mg tid (4.8 g/day) administered orally PT20: Modified ferric oxide adipate	Group 4 - PT20 3200 mg Tid PT20 3200 mg tid (9.6 g/day) administered orally PT20: Modified ferric oxide adipate	Group 5 - Placebo Tid Matched Placebo (for PT20) tid administered orally Placebo: Placebo tablets matched to each active PT20 dosage arm
Overall Study Adverse Event	2	0	1	4	0
Overall Study Withdrawal by Subject	0	1	1	1	1
Overall Study Hyperphosphataemia	1	0	0	0	1
Overall Study High Ferritin levels	3	3	2	2	1

Baseline Characteristics

Study to Evaluate the Efficacy and Safety of PT20 in Subjects With Hyperphosphataemia and Dialysis Dependent Chronic Kidney Disease

Baseline characteristics by cohort

Measure	Group 1 - PT20 400 mg Tid n=24 Participants PT20 400 mg tid (1.2 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 2 - PT20 800 mg Tid n=23 Participants PT20 800 mg tid (2.4 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 3 - PT20 1600 mg Tid n=22 Participants PT20 1600 mg tid (4.8 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 4 - PT20 3200 mg Tid n=36 Participants PT20 3200 mg tid (9.6 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 5 - Placebo Tid n=36 Participants Matched Placebo (for PT20) tid administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Total n=141 Participants Total of all reporting groups
Age, Continuous	60.4 years n=5 Participants	58.0 years n=7 Participants	60.3 years n=5 Participants	55.9 years n=4 Participants	55.0 years n=21 Participants	57.5 years n=8 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	16 Participants n=4 Participants	14 Participants n=21 Participants	58 Participants n=8 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	14 Participants n=7 Participants	11 Participants n=5 Participants	20 Participants n=4 Participants	22 Participants n=21 Participants	83 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	14 Participants n=4 Participants	13 Participants n=21 Participants	53 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	14 Participants n=7 Participants	14 Participants n=5 Participants	22 Participants n=4 Participants	23 Participants n=21 Participants	88 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	12 Participants n=4 Participants	16 Participants n=21 Participants	52 Participants n=8 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	20 Participants n=4 Participants	16 Participants n=21 Participants	72 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	7 Participants n=8 Participants
Region of Enrollment United States	24 Participants n=5 Participants	23 Participants n=7 Participants	22 Participants n=5 Participants	36 Participants n=4 Participants	36 Participants n=21 Participants	141 Participants n=8 Participants
Baseline Serum Phosphate Concentrations < 7.5 mg/dL	13 Participants n=5 Participants	15 Participants n=7 Participants	11 Participants n=5 Participants	20 Participants n=4 Participants	20 Participants n=21 Participants	79 Participants n=8 Participants
Baseline Serum Phosphate Concentrations ≥ 7.5 mg/dL	11 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	16 Participants n=4 Participants	16 Participants n=21 Participants	62 Participants n=8 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 29

Population: Intent-to-Treat (ITT) population.

The primary efficacy endpoint was the change in serum phosphate concentration from Baseline (Visit 7, Day 1) to Visit 11 (Day 29). All study specific blood samples were collected, processed and analysed using a central laboratory.

Outcome measures

Measure	Group 1 - PT20 400 mg Tid n=20 Participants PT20 400 mg tid (1.2 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 2 - PT20 800 mg Tid n=20 Participants PT20 800 mg tid (2.4 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 3 - PT20 1600 mg Tid n=20 Participants PT20 1600 mg tid (4.8 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 4 - PT20 3200 mg Tid n=32 Participants PT20 3200 mg tid (9.6 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 5 - Placebo Tid n=35 Participants Matched Placebo (for PT20) tid administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
Change in Serum Phosphate Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)	-0.4 mg/dL Interval -3.1 to 3.5	-0.59 mg/dL Interval -4.9 to 2.6	-1.29 mg/dL Interval -4.6 to 1.5	-1.363 mg/dL Interval -5.2 to 4.6	-0.165 mg/dL Interval -2.5 to 2.4

SECONDARY outcome

Timeframe: Day 1 to Day 29

Population: ITT population.

Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in haemoglobin concentration. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Visit 11 (Day 29), which were to include the fixed, categorical effects of treatment as well as the continuous, fixed covariates of Baseline concentrations for haemoglobin. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis.

Outcome measures

Measure	Group 1 - PT20 400 mg Tid n=19 Participants PT20 400 mg tid (1.2 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 2 - PT20 800 mg Tid n=19 Participants PT20 800 mg tid (2.4 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 3 - PT20 1600 mg Tid n=20 Participants PT20 1600 mg tid (4.8 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 4 - PT20 3200 mg Tid n=31 Participants PT20 3200 mg tid (9.6 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 5 - Placebo Tid n=29 Participants Matched Placebo (for PT20) tid administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
Change in Haemoglobin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)	0.02 g/dL Standard Deviation 0.953	-0.25 g/dL Standard Deviation 1.085	-0.22 g/dL Standard Deviation 0.958	0.18 g/dL Standard Deviation 0.913	-0.13 g/dL Standard Deviation 0.892

SECONDARY outcome

Timeframe: Day 1 to Day 29

Population: ITT population.

Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in serum ferritin concentration. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Visit 11 (Day 29), which were to include the fixed, categorical effects of treatment and week (Visit), as well as the continuous, fixed covariates of Baseline concentrations for serum ferritin. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis.

Outcome measures

Measure	Group 1 - PT20 400 mg Tid n=20 Participants PT20 400 mg tid (1.2 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 2 - PT20 800 mg Tid n=20 Participants PT20 800 mg tid (2.4 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 3 - PT20 1600 mg Tid n=20 Participants PT20 1600 mg tid (4.8 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 4 - PT20 3200 mg Tid n=31 Participants PT20 3200 mg tid (9.6 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 5 - Placebo Tid n=34 Participants Matched Placebo (for PT20) tid administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
Change in Serum Ferritin Concentration From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)	50 ng/mL Standard Deviation 206.23	48.8 ng/mL Standard Deviation 231.41	10.1 ng/mL Standard Deviation 107.05	69.9 ng/mL Standard Deviation 172.85	-67.0 ng/mL Standard Deviation 181.73

SECONDARY outcome

Timeframe: Day 1 to Day 29

Population: ITT population.

Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in transferrin saturation. An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Day 29 (Visit 11), which were to include the fixed, categorical effects of treatment and week, as well as the continuous, fixed covariates of Baseline concentrations for transferrin saturation. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis.

Outcome measures

Measure	Group 1 - PT20 400 mg Tid n=20 Participants PT20 400 mg tid (1.2 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 2 - PT20 800 mg Tid n=20 Participants PT20 800 mg tid (2.4 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 3 - PT20 1600 mg Tid n=19 Participants PT20 1600 mg tid (4.8 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 4 - PT20 3200 mg Tid n=29 Participants PT20 3200 mg tid (9.6 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 5 - Placebo Tid n=33 Participants Matched Placebo (for PT20) tid administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
Change in Transferrin Saturation From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)	2.20 percent Standard Deviation 8.649	0.40 percent Standard Deviation 11.856	5.84 percent Standard Deviation 15.178	-4.59 percent Standard Deviation 14.735	-0.45 percent Standard Deviation 8.754

SECONDARY outcome

Timeframe: Day 1 to Day 29

Population: ITT population.

Descriptive statistics were to be used to summarise values and change from Baseline (Visit 7, Day 1) to Day 29 (Visit 11) in Calcium x Phosphate Product . An analysis of covariance (ANCOVA) was to be used to analyse the changes from Baseline (Visit 7, Day 1) to Day 29 (Visit 11), which were to include the fixed, categorical effects of treatment, as well as the continuous, fixed covariates of Baseline concentrations for Calcium x Phosphate Product. Only those subjects with available concentrations for both Baseline (Visit 7, Day 1) and Visit 11 (Day 29) were to be included in this analysis. In CKD subjects (Stages 3-5), the clinical recommendation (KDOQI) is that serum calcium x phosphate product should be maintained at < 55 mg^2/dL^2 (4.4 mmol^2 /L^2).

Outcome measures

Measure	Group 1 - PT20 400 mg Tid n=17 Participants PT20 400 mg tid (1.2 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 2 - PT20 800 mg Tid n=16 Participants PT20 800 mg tid (2.4 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 3 - PT20 1600 mg Tid n=16 Participants PT20 1600 mg tid (4.8 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 4 - PT20 3200 mg Tid n=26 Participants PT20 3200 mg tid (9.6 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 5 - Placebo Tid n=27 Participants Matched Placebo (for PT20) tid administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
Change in Calcium x Phosphate Product From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)	-5.515 mg^2/dL^2 Standard Deviation 13.7966	-4.035 mg^2/dL^2 Standard Deviation 13.5196	-11.127 mg^2/dL^2 Standard Deviation 15.1683	-10.996 mg^2/dL^2 Standard Deviation 19.3057	-0.778 mg^2/dL^2 Standard Deviation 10.286

SECONDARY outcome

Timeframe: Day 1 to Day 29

Population: Safety Set

The GSRS assesses the impact of treatment-related GI complications. It includes 15 items divided into 5 subscales (diarrhoea, indigestion, abdominal pain, constipation, and reflux), and uses a seven-grade Likert scale to assess symptoms (1 = no discomfort at all, 7 = very severe discomfort). The total score was calculated as the average score of all 15 items. If data were missing from one or more subscales, the mean of the completed items within the subscale was to be used for the subscale score, provided that more than half of the subscale items were complete. If more than half of the items within a subscale were missing, the subscale score and overall score were also to be defined as missing. The change in overall GSRS score from Baseline (Visit 7, Day 1) to Visit 11 (Day 29) was summarised by treatment and a two-sample t-test was to be used to identify differences between the placebo and PT20 dose groups. The higher the score, the more severe the gastrointestinal symptoms.

Outcome measures

Measure	Group 1 - PT20 400 mg Tid n=22 Participants PT20 400 mg tid (1.2 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 2 - PT20 800 mg Tid n=21 Participants PT20 800 mg tid (2.4 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 3 - PT20 1600 mg Tid n=19 Participants PT20 1600 mg tid (4.8 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 4 - PT20 3200 mg Tid n=31 Participants PT20 3200 mg tid (9.6 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 5 - Placebo Tid n=34 Participants Matched Placebo (for PT20) tid administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
Change in Gastrointestinal Symptom Rating System (GSRS) Overall Score From Baseline (Visit 7, Day 1) to Visit 11 (Day 29)	-0.9 score on a scale Standard Deviation 3.75	2.8 score on a scale Standard Deviation 5.97	0.4 score on a scale Standard Deviation 9.80	1.6 score on a scale Standard Deviation 8.48	0.1 score on a scale Standard Deviation 5.16

Adverse Events

Group 1 - PT20 400 mg Tid

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Group 2 - PT20 800 mg Tid

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Group 3 - PT20 1600 mg Tid

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Group 4 - PT20 3200 mg Tid

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

Group 5 - Placebo Tid

Serious events: 5 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 - PT20 400 mg Tid n=24 participants at risk PT20 400 mg tid (1.2 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 2 - PT20 800 mg Tid n=23 participants at risk PT20 800 mg tid (2.4 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 3 - PT20 1600 mg Tid n=22 participants at risk PT20 1600 mg tid (4.8 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 4 - PT20 3200 mg Tid n=36 participants at risk PT20 3200 mg tid (9.6 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 5 - Placebo Tid n=36 participants at risk Matched Placebo (for PT20) tid administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
Infections and infestations Arthritis bacterial	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Infections and infestations Osteomyelitis	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Infections and infestations Pneumonia	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Infections and infestations Urinary tract infection	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Cardiac disorders Acute coronary syndrome	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
General disorders Catheter site pain	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.5% 1/22 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.3% 1/23 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Vascular disorders Femoral artery aneurysm	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.

Other adverse events

Measure	Group 1 - PT20 400 mg Tid n=24 participants at risk PT20 400 mg tid (1.2 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 2 - PT20 800 mg Tid n=23 participants at risk PT20 800 mg tid (2.4 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 3 - PT20 1600 mg Tid n=22 participants at risk PT20 1600 mg tid (4.8 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 4 - PT20 3200 mg Tid n=36 participants at risk PT20 3200 mg tid (9.6 g/day) administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study	Group 5 - Placebo Tid n=36 participants at risk Matched Placebo (for PT20) tid administered orally. Dosing was initiated with the subject's first meal/snack following receipt of study medication at Visit 7 (Day 1). There was to be no change in dose administration level with respect to each cohort in this study
Gastrointestinal disorders Diarrhoea	12.5% 3/24 • Number of events 3 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	13.0% 3/23 • Number of events 3 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	18.2% 4/22 • Number of events 4 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	16.7% 6/36 • Number of events 6 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	5.6% 2/36 • Number of events 2 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Gastrointestinal disorders Faeces discoloured	8.3% 2/24 • Number of events 2 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	13.0% 3/23 • Number of events 3 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	22.7% 5/22 • Number of events 5 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Gastrointestinal disorders Constipation	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	11.1% 4/36 • Number of events 4 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Gastrointestinal disorders Nausea	8.3% 2/24 • Number of events 2 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	8.7% 2/23 • Number of events 2 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Gastrointestinal disorders Vomiting	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.3% 1/23 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	8.3% 3/36 • Number of events 3 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.5% 1/22 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Gastrointestinal disorders Abdominal pain upper	4.2% 1/24 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	9.1% 2/22 • Number of events 2 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Gastrointestinal disorders Dyspepsia	4.2% 1/24 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.3% 1/23 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Gastrointestinal disorders Abdominal distension	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	5.6% 2/36 • Number of events 2 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Gastrointestinal disorders Flatulence	4.2% 1/24 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Gastrointestinal disorders Gastro-oesophageal reflux disease	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	5.6% 2/36 • Number of events 2 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Gastrointestinal disorders Toothache	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	8.7% 2/23 • Number of events 2 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Gastrointestinal disorders Dysphagia	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.5% 1/22 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Gastrointestinal disorders Haematochezia	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.5% 1/22 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Gastrointestinal disorders Abdominal pain	4.2% 1/24 • Number of events 2 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Infections and infestations Upper respiratory tract infection	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	9.1% 2/22 • Number of events 2 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	5.6% 2/36 • Number of events 3 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Infections and infestations Urinary tract infection	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	5.6% 2/36 • Number of events 2 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Infections and infestations Influenza	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.5% 1/22 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.3% 2/24 • Number of events 2 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.3% 1/23 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Musculoskeletal and connective tissue disorders Back pain	4.2% 1/24 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	5.6% 2/36 • Number of events 2 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
General disorders Chest pain	4.2% 1/24 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Cardiac disorders Tachycardia	4.2% 1/24 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.5% 1/22 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Psychiatric disorders Anxiety	4.2% 1/24 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	2.8% 1/36 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Infections and infestations Gastroenteritis viral	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.5% 1/22 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Infections and infestations Sinusitis	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.3% 1/23 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.5% 1/22 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Metabolism and nutrition disorders Neck pain	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.3% 1/23 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
General disorders Chills	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.3% 1/23 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.3% 1/23 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.3% 1/23 • Number of events 2 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.5% 1/22 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.3% 1/23 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Skin and subcutaneous tissue disorders Pruritus	4.2% 1/24 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Nervous system disorders Syncope	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.3% 1/23 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Vascular disorders Hypertension	4.2% 1/24 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Vascular disorders Hypotension	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.5% 1/22 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Vascular disorders Malignant hypertension	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.5% 1/22 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Eye disorders Eye irritation	4.2% 1/24 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Eye disorders Vision blurred	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.5% 1/22 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Investigations Breath sounds abnormal	4.2% 1/24 • Number of events 6 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/22 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal cancer	0.00% 0/24 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/23 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	4.5% 1/22 • Number of events 1 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.	0.00% 0/36 • All AEs that occurred from the point a subject signed the informed consent form until study completion up to 13 weeks later were to be reported on the eCRF. Any SAE that occurred from the point of a subject signing the informed consent form to within 28 days of the last study visit (as self-reported by subject, up to 17 weeks after informed consent) was to be reported by the Investigator within the eCRF or by fax or telephone within 24 h of awareness of the event. Subjects were expected to volunteer information about AEs they experienced. The Investigator/designee also questioned the subject at each visit about AEs and recorded these as well as all other AEs apparent. AEs/SAEs were monitored until they were resolved or determined to be due to a subject's on-going condition or inter-current illness.

Additional Information

Mark Sampson

Shield Therapeutics

Phone: +44 (0) 207 186 8500

Email: msampson@shieldtx.com

Results disclosure agreements

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