Trial Outcomes & Findings for Study of Safety and Efficacy of LNP023 in Patients With Kidney Disease Caused by Inflammation (NCT NCT03373461)

NCT ID: NCT03373461

Last Updated: 2023-01-30

Results Overview

The primary analysis of the dose-response effect of LNP023 versus placebo on the reduction in UPCR 24 hours at Day 90 was done using Multiple Comparison Procedure Modelling (MCP-Mod). The existence of a dose-response relationship was assessed at the MCP step at the one-sided 10% significance level vis a multiple contrasts test. In the Mod step, the mean predicted difference between each LNP023 dose and placebo were then estimated using parametric bootstrap model averaging. Results are presented on the original scale as geometric mean ratios. A ratio less than 1 indicates a reduction in proteinuria. Participants collected all urine over a 24 hour period for UPCR test.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

112 participants

Primary outcome timeframe

Baseline and Day 90

Results posted on

2023-01-30

Participant Flow

There were 99 participants screened and 46 randomized participants completed in Part 1. There were 162 screened in Part 2 and 66 were randomized. All participants completed a run-in period of at least 30 days. Participants randomized to Part 1 could not participate in Part 2.

Participant milestones

Participant milestones
Measure	LNP023 10 mg BID 10 mg taken twice a day	LNP023 50 mg BID 50 mg taken twice a day	LNP023 100 mg BID - Part 2 100 mg taken orally twice a day	LNP023 200 mg BID 200 mg taken twice a day	Placebo Placebo identical to LNP023 taken orally twice a day
Part 1 STARTED	9	8	0	15	14
Part 1 COMPLETED	9	8	0	15	14
Part 1 NOT COMPLETED	0	0	0	0	0
Part 2 STARTED	11	11	22	11	11
Part 2 COMPLETED	11	10	22	11	10
Part 2 NOT COMPLETED	0	1	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	LNP023 10 mg BID 10 mg taken twice a day	LNP023 50 mg BID 50 mg taken twice a day	LNP023 100 mg BID - Part 2 100 mg taken orally twice a day	LNP023 200 mg BID 200 mg taken twice a day	Placebo Placebo identical to LNP023 taken orally twice a day
Part 2 Adverse Event	0	1	0	0	1

Baseline Characteristics

Blood pressure measurements not available for all participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LNP023 10 mg BID n=20 Participants 10 mg taken twice a day	LNP023 50 mg BID n=19 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=22 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=26 Participants 200 mg taken twice a day	Placebo n=25 Participants Placebo identical to LNP023 taken orally twice a day	Total n=112 Participants Total of all reporting groups
Age, Continuous	39.2 years STANDARD_DEVIATION 12.42 • n=20 Participants	36.6 years STANDARD_DEVIATION 8.42 • n=19 Participants	36.0 years STANDARD_DEVIATION 13.15 • n=22 Participants	42.5 years STANDARD_DEVIATION 15.76 • n=26 Participants	39.4 years STANDARD_DEVIATION 11.00 • n=25 Participants	38.9 years STANDARD_DEVIATION 12.58 • n=112 Participants
Age, Customized 18 years - <65 years	20 Participants n=20 Participants	19 Participants n=19 Participants	21 Participants n=22 Participants	24 Participants n=26 Participants	25 Participants n=25 Participants	109 Participants n=112 Participants
Age, Customized 65 years - <85 years	0 Participants n=20 Participants	0 Participants n=19 Participants	1 Participants n=22 Participants	2 Participants n=26 Participants	0 Participants n=25 Participants	3 Participants n=112 Participants
Sex: Female, Male Female	11 Participants n=20 Participants	6 Participants n=19 Participants	11 Participants n=22 Participants	11 Participants n=26 Participants	7 Participants n=25 Participants	46 Participants n=112 Participants
Sex: Female, Male Male	9 Participants n=20 Participants	13 Participants n=19 Participants	11 Participants n=22 Participants	15 Participants n=26 Participants	18 Participants n=25 Participants	66 Participants n=112 Participants
Race/Ethnicity, Customized Asian	10 Participants n=20 Participants	9 Participants n=19 Participants	12 Participants n=22 Participants	12 Participants n=26 Participants	11 Participants n=25 Participants	54 Participants n=112 Participants
Race/Ethnicity, Customized White	10 Participants n=20 Participants	9 Participants n=19 Participants	10 Participants n=22 Participants	13 Participants n=26 Participants	13 Participants n=25 Participants	55 Participants n=112 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=20 Participants	1 Participants n=19 Participants	0 Participants n=22 Participants	1 Participants n=26 Participants	0 Participants n=25 Participants	2 Participants n=112 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=20 Participants	0 Participants n=19 Participants	0 Participants n=22 Participants	0 Participants n=26 Participants	1 Participants n=25 Participants	1 Participants n=112 Participants
Urine Protein to Creatinine Ratio (UPCR)	214.1 g/mol STANDARD_DEVIATION 122.29 • n=20 Participants	188.2 g/mol STANDARD_DEVIATION 90.38 • n=19 Participants	203.4 g/mol STANDARD_DEVIATION 98.29 • n=22 Participants	151.0 g/mol STANDARD_DEVIATION 109.46 • n=26 Participants	146.6 g/mol STANDARD_DEVIATION 61.62 • n=25 Participants	177.9 g/mol STANDARD_DEVIATION 100.02 • n=112 Participants
Estimated Glomerular Filtration Rate (eGFR)	66.0 mL/min/1.73m^2 STANDARD_DEVIATION 28.51 • n=20 Participants	53.8 mL/min/1.73m^2 STANDARD_DEVIATION 22.73 • n=19 Participants	67.0 mL/min/1.73m^2 STANDARD_DEVIATION 31.75 • n=22 Participants	57.9 mL/min/1.73m^2 STANDARD_DEVIATION 28.92 • n=26 Participants	65.7 mL/min/1.73m^2 STANDARD_DEVIATION 32.60 • n=25 Participants	62.2 mL/min/1.73m^2 STANDARD_DEVIATION 29.30 • n=112 Participants
Supine Blood Pressure Systolic	134.4 mmHg STANDARD_DEVIATION 11.65 • n=12 Participants • Blood pressure measurements not available for all participants	122.6 mmHg STANDARD_DEVIATION 12.15 • n=12 Participants • Blood pressure measurements not available for all participants	125.0 mmHg STANDARD_DEVIATION 11.30 • n=11 Participants • Blood pressure measurements not available for all participants	125.7 mmHg STANDARD_DEVIATION 11.66 • n=18 Participants • Blood pressure measurements not available for all participants	125.5 mmHg STANDARD_DEVIATION 11.37 • n=17 Participants • Blood pressure measurements not available for all participants	126.5 mmHg STANDARD_DEVIATION 11.89 • n=70 Participants • Blood pressure measurements not available for all participants
Supine Blood Pressure Diastolic	84.1 mmHg STANDARD_DEVIATION 7.65 • n=12 Participants • Blood pressure measurements not available for all participants	76.9 mmHg STANDARD_DEVIATION 8.41 • n=12 Participants • Blood pressure measurements not available for all participants	80.0 mmHg STANDARD_DEVIATION 10.40 • n=11 Participants • Blood pressure measurements not available for all participants	79.7 mmHg STANDARD_DEVIATION 7.62 • n=18 Participants • Blood pressure measurements not available for all participants	78.2 mmHg STANDARD_DEVIATION 7.32 • n=17 Participants • Blood pressure measurements not available for all participants	79.6 mmHg STANDARD_DEVIATION 8.26 • n=70 Participants • Blood pressure measurements not available for all participants
Prior use of ACEi and/or ARB	19 Participants n=20 Participants	19 Participants n=19 Participants	22 Participants n=22 Participants	26 Participants n=26 Participants	25 Participants n=25 Participants	111 Participants n=112 Participants

PRIMARY outcome

Timeframe: Baseline and Day 90

Population: Full analysis set - all randomized patients with a baseline and at least one post-baseline value

The primary analysis of the dose-response effect of LNP023 versus placebo on the reduction in UPCR 24 hours at Day 90 was done using Multiple Comparison Procedure Modelling (MCP-Mod). The existence of a dose-response relationship was assessed at the MCP step at the one-sided 10% significance level vis a multiple contrasts test. In the Mod step, the mean predicted difference between each LNP023 dose and placebo were then estimated using parametric bootstrap model averaging. Results are presented on the original scale as geometric mean ratios. A ratio less than 1 indicates a reduction in proteinuria. Participants collected all urine over a 24 hour period for UPCR test.

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=19 Participants 10 mg taken twice a day	LNP023 50 mg BID n=19 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=22 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=26 Participants 200 mg taken twice a day	Placebo n=25 Participants Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
MCP-Mod Estimates of the Ratio to Baseline of Urine Protein to Creatinine Ratio (UPCR) (g/Mol) - Parts 1 and 2 at Day 90	0.85 Ratio to baseline Interval 0.77 to 0.93	0.80 Ratio to baseline Interval 0.73 to 0.87	0.76 Ratio to baseline Interval 0.7 to 0.81	0.69 Ratio to baseline Interval 0.61 to 0.77	0.88 Ratio to baseline Interval 0.8 to 1.0	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 90

Population: Full analysis set - all randomized patients with a baseline and at least one post-baseline value

eGFR was calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). The CKD-EPI equation is an established, widely used and Kidney Disease Improving Global Outcomes (KDIGO) guideline recommended method of GFR estimation based on serum creatinine, age, gender and race of the patient. It was derived and validated established from a meta-analyses of multiple studies including large number of patients.

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=20 Participants 10 mg taken twice a day	LNP023 50 mg BID n=19 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=22 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=26 Participants 200 mg taken twice a day	Placebo n=25 Participants Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Estimated Glomerular Filtration Rate (eGFR) - Parts 1 and 2 at Day 90	-0.06 mL/min/SSA Standard Error 1.760	2.49 mL/min/SSA Standard Error 1.859	0.23 mL/min/SSA Standard Error 1.821	2.42 mL/min/SSA Standard Error 1.545	-3.34 mL/min/SSA Standard Error 1.606	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 90

Population: Full analysis set - all randomized patients with a baseline and at least one post-baseline value

Serum creatinine

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=20 Participants 10 mg taken twice a day	LNP023 50 mg BID n=19 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=22 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=26 Participants 200 mg taken twice a day	Placebo n=25 Participants Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Serum Creatinine - Parts 1 and 2 at Day 90	-2.55 umol/L Standard Error 3.488	-2.60 umol/L Standard Error 3.665	0.76 umol/L Standard Error 3.555	-3.47 umol/L Standard Error 3.043	6.65 umol/L Standard Error 3.150	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 90

Population: Full analysis set - all randomized patients with both baseline and Day 90 hematuria values. The number of participants analyzed corresponds to the column totals (i.e. the number of patients with non-missing baseline and day 90 values by hematuria level at Day 90 and treatment group).

Hematuria levels were the number of erythrocytes/high-power-field (hpf) measured through microscopic examination. The table shows the shift in hematuria grade (Low: \<9 rbc/hpf, Intermediate: \>=9 to \<= 50 rbc/hpf, High: \>50 rbc/hpf) from baseline (rows) to Day 90 (columns). A lower grade corresponds to a better outcome. Only patients with both baseline and Day 90 hematuria values are presented. L=low, I=intermediate and H=high in column headings for doses and BL=baseline

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=8 Participants 10 mg taken twice a day	LNP023 50 mg BID n=4 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 100 mg taken orally twice a day	LNP023 200 mg BID n=14 Participants 200 mg taken twice a day	Placebo n=1 Participants Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L n=12 Participants L (\<9 rbc/hpf) at Day 90	100mg-I n=1 Participants I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L n=12 Participants L (\<9 rbc/hpf) at Day 90	200mg-I n=2 Participants I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L n=10 Participants L (\<9 rbc/hpf) at Day 90	PL-I n=2 Participants I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H n=1 Participants H (\>50 rbc/hpf) at Day 90
Shift Table From Baseline for Hematuria Levels - Parts 1 and 2 at Day 90 Low at baseline	7 participants	1 participants	—	13 participants	0 participants	—	6 participants	0 participants	—	6 participants	0 participants	—	6 participants	2 participants	0 participants
Shift Table From Baseline for Hematuria Levels - Parts 1 and 2 at Day 90 High at baseline	0 participants	0 participants	—	0 participants	0 participants	—	2 participants	1 participants	—	0 participants	0 participants	—	0 participants	0 participants	0 participants
Shift Table From Baseline for Hematuria Levels - Parts 1 and 2 at Day 90 Intermediate at baseline	1 participants	3 participants	—	1 participants	1 participants	—	4 participants	0 participants	—	6 participants	2 participants	—	4 participants	0 participants	1 participants

SECONDARY outcome

Timeframe: Baseline and Day 90

Population: Full analysis set - all randomized patients with a baseline and at least one post-baseline value

Participants collected all of their urine over a 24-hour period.

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=19 Participants 10 mg taken twice a day	LNP023 50 mg BID n=19 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=22 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=26 Participants 200 mg taken twice a day	Placebo n=25 Participants Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in 24hour Urine Protein (UP) - Parts 1 and 2 to Day 90	0.80 Ratio to baseline Interval 0.661 to 0.965	0.89 Ratio to baseline Interval 0.74 to 1.07	0.61 Ratio to baseline Interval 0.509 to 0.729	0.70 Ratio to baseline Interval 0.601 to 0.823	0.84 Ratio to baseline Interval 0.713 to 0.987	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 90

Population: Full analysis set - all randomized patients with a baseline and at least one post-baseline value

Participants collected all of their urine over a 24-hour period.

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=19 Participants 10 mg taken twice a day	LNP023 50 mg BID n=19 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=22 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=26 Participants 200 mg taken twice a day	Placebo n=25 Participants Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline of 24 Hour Urine Albumin (UA) - Parts 1 and 2 to Day 90	0.79 Ratio to baseline Interval 0.648 to 0.964	0.93 Ratio to baseline Interval 0.763 to 1.122	0.61 Ratio to baseline Interval 0.504 to 0.734	0.73 Ratio to baseline Interval 0.623 to 0.865	0.82 Ratio to baseline Interval 0.693 to 0.973	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 90

Population: Full analysis set - all randomized patients with a baseline and at least one post-baseline value

Participants collected all of their urine over a 24-hour period.

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=19 Participants 10 mg taken twice a day	LNP023 50 mg BID n=19 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=22 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=26 Participants 200 mg taken twice a day	Placebo n=25 Participants Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in 24 Hour Urine Albumin to Creatinine (UACR) - Parts 1 and 2 to Day 90	0.85 Ratio to baseline Interval 0.728 to 0.998	0.89 Ratio to baseline Interval 0.765 to 1.045	0.66 Ratio to baseline Interval 0.567 to 0.772	0.74 Ratio to baseline Interval 0.647 to 0.842	0.87 Ratio to baseline Interval 0.756 to 0.998	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 90

Population: Full analysis set - all randomized patients with a baseline and at least one post-baseline value

A midstream urine sample was obtained from the first morning void (FMV) on the visit day.

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=20 Participants 10 mg taken twice a day	LNP023 50 mg BID n=19 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=22 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=26 Participants 200 mg taken twice a day	Placebo n=25 Participants Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in Urine Protein to Creatinine (UPCR) From 1st Morning Void - Parts 1 and 2 at Day 90	0.76 Ratio to baseline Interval 0.638 to 0.908	0.81 Ratio to baseline Interval 0.674 to 0.97	0.61 Ratio to baseline Interval 0.509 to 0.725	0.70 Ratio to baseline Interval 0.598 to 0.815	0.83 Ratio to baseline Interval 0.704 to 0.97	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (0 hr), Day 15 (0 hr) Day 30 (0, 0.25, 0.5, 1, 2, 4, 6, 8 hrs)

Population: PK analyses set - number of participants with evaluable results for each parameter

AUClast,ss: the area under the plasma concentration-time curve from time zero to last quantifiable concentration at steady state AUCtau,ss: the area under the plasma concentration-time curve from time zero to the end of the dosing interval tau at steady state

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=18 Participants 10 mg taken twice a day	LNP023 50 mg BID n=18 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=16 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=24 Participants 200 mg taken twice a day	Placebo Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Plasma Pharmacokinetics (PK) of Area Under the Curve at Steady State (AUCtau,ss and AUClast,ss) at Day 30 AUClast,ss	5820 hr*ng/mL Standard Deviation 1750	13000 hr*ng/mL Standard Deviation 2740	18400 hr*ng/mL Standard Deviation 6040	27900 hr*ng/mL Standard Deviation 9930	—	—	—	—	—	—	—	—	—	—	—
Plasma Pharmacokinetics (PK) of Area Under the Curve at Steady State (AUCtau,ss and AUClast,ss) at Day 30 AUCtau,ss	8010 hr*ng/mL Standard Deviation 2550	17700 hr*ng/mL Standard Deviation 4250	24700 hr*ng/mL Standard Deviation 8030	37100 hr*ng/mL Standard Deviation 13500	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (0 hr), Day 15 (0 hr) Day 30 (0, 0.25, 0.5, 1, 2, 4, 6, 8 hrs)

Population: PK analyses set - number of participants with evaluable results for each parameter

Cmax,ss: the observed maximum plasma concentration following drug administration at steady state (ng/mL) Ctrough,ss: the pre-dose plasma concentration observed during a dosing interval at steady state (ng/mL)

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=18 Participants 10 mg taken twice a day	LNP023 50 mg BID n=18 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=16 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=24 Participants 200 mg taken twice a day	Placebo Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Plasma Pharmacokinetics (PK) of Pre-dose Trough at Steady State (Ctrough,ss) and Maximum Concentrations (Cmax,ss) at Day 30 Ctrough,ss	515 ng/mL Standard Deviation 232	1130 ng/mL Standard Deviation 348	1510 ng/mL Standard Deviation 567	2200 ng/mL Standard Deviation 964	—	—	—	—	—	—	—	—	—	—	—
Plasma Pharmacokinetics (PK) of Pre-dose Trough at Steady State (Ctrough,ss) and Maximum Concentrations (Cmax,ss) at Day 30 Cmax,ss	964 ng/mL Standard Deviation 264	2150 ng/mL Standard Deviation 480	3300 ng/mL Standard Deviation 1080	4940 ng/mL Standard Deviation 1770	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (0 hr), Day 15 (0 hr) Day 30 (0, 0.25, 0.5, 1, 2, 4, 6, 8 hrs)

Population: PK analyses set - number of participants with evaluable results for each parameter

Tmax,ss: the time to reach the maximum concentration after drug administration at steady state (h)

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=18 Participants 10 mg taken twice a day	LNP023 50 mg BID n=18 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=16 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=24 Participants 200 mg taken twice a day	Placebo Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Plasma Pharmacokinetics (PK) of Time to Maximum Concentration at Steady State (Tmax,ss) at Day 30	2.00 hour Interval 0.25 to 6.0	2.00 hour Interval 1.0 to 6.0	2.00 hour Interval 0.5 to 6.0	2.00 hour Interval 0.5 to 4.0	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 30

Population: PK analyses set - number of participants with evaluable results for each parameter

Ae,ss: the total cumulative urinary excretion at steady state

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=16 Participants 10 mg taken twice a day	LNP023 50 mg BID n=14 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=14 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=22 Participants 200 mg taken twice a day	Placebo Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Amount of LNP023 Excreted Into Urine (Ae,ss) at Day 30	1.72 mg Standard Deviation 1.15	11.7 mg Standard Deviation 5.84	30.9 mg Standard Deviation 17.0	60.3 mg Standard Deviation 27.1	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 30

Population: PK analyses set - number of participants with evaluable results for each parameter

Percent of drug excreted into the urine

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=16 Participants 10 mg taken twice a day	LNP023 50 mg BID n=14 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=14 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=22 Participants 200 mg taken twice a day	Placebo Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Percent of LNP023 Excreted Into Urine at Day 30	8.59 percent of dose Standard Deviation 5.77	11.7 percent of dose Standard Deviation 5.84	15.5 percent of dose Standard Deviation 8.50	15.1 percent of dose Standard Deviation 6.77	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 30

Population: PK analyses set - number of participants with evaluable results for each parameter

The renal clearance from plasma at steady state

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=16 Participants 10 mg taken twice a day	LNP023 50 mg BID n=14 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=14 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=22 Participants 200 mg taken twice a day	Placebo Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Renal Clearance From Plasma at Steady State (CLr,ss) at Day 30	0.112 L/hr Standard Deviation 0.0744	0.348 L/hr Standard Deviation 0.179	0.719 L/hr Standard Deviation 0.479	0.942 L/hr Standard Deviation 0.540	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Days 8, 15, 30, 60, 90

Population: Full analysis set - all randomized patients with with a baseline and at least one post-baseline value

The complement AP biomarkers Bb and sC5b-9 were evaluated as potential pharmacodynamics and mode-of-action markers. Both biomarkers were measured using validated enzyme-linked immunosorbent assays (ELISAs).

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=20 Participants 10 mg taken twice a day	LNP023 50 mg BID n=19 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=22 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=26 Participants 200 mg taken twice a day	Placebo n=25 Participants Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) and Soluble Terminal Complement Complex (sC5b-9) Biomarkers for Parts 1 and 2 to Day 90 Day 60 sC5B-9, n=14,16,17,24,20	84.6 ng/mL Geometric Coefficient of Variation 27.37	73.7 ng/mL Geometric Coefficient of Variation 31.99	74.9 ng/mL Geometric Coefficient of Variation 29.65	76.2 ng/mL Geometric Coefficient of Variation 29.80	95.7 ng/mL Geometric Coefficient of Variation 30.11	—	—	—	—	—	—	—	—	—	—
Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) and Soluble Terminal Complement Complex (sC5b-9) Biomarkers for Parts 1 and 2 to Day 90 Day 8 - Bb, n=14,16,13,25,19	76.7 ng/mL Geometric Coefficient of Variation 22.89	72.2 ng/mL Geometric Coefficient of Variation 22.86	71.4 ng/mL Geometric Coefficient of Variation 30.66	66.3 ng/mL Geometric Coefficient of Variation 28.15	102.7 ng/mL Geometric Coefficient of Variation 19.78	—	—	—	—	—	—	—	—	—	—
Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) and Soluble Terminal Complement Complex (sC5b-9) Biomarkers for Parts 1 and 2 to Day 90 Day 15 - Bb, n=13,14,16,22,22	80.4 ng/mL Geometric Coefficient of Variation 32.59	74.1 ng/mL Geometric Coefficient of Variation 23.30	78.5 ng/mL Geometric Coefficient of Variation 33.35	72.9 ng/mL Geometric Coefficient of Variation 20.47	108.6 ng/mL Geometric Coefficient of Variation 23.19	—	—	—	—	—	—	—	—	—	—
Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) and Soluble Terminal Complement Complex (sC5b-9) Biomarkers for Parts 1 and 2 to Day 90 Day 30 - Bb, n=16,17,18,26,24	76.4 ng/mL Geometric Coefficient of Variation 18.32	76.2 ng/mL Geometric Coefficient of Variation 23.62	76.8 ng/mL Geometric Coefficient of Variation 34.00	70.4 ng/mL Geometric Coefficient of Variation 28.96	99.3 ng/mL Geometric Coefficient of Variation 22.07	—	—	—	—	—	—	—	—	—	—
Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) and Soluble Terminal Complement Complex (sC5b-9) Biomarkers for Parts 1 and 2 to Day 90 Day 60 - Bb, n=14,16,17,25,21	78.8 ng/mL Geometric Coefficient of Variation 20.26	75.2 ng/mL Geometric Coefficient of Variation 19.05	77.4 ng/mL Geometric Coefficient of Variation 35.23	72.8 ng/mL Geometric Coefficient of Variation 23.97	102.9 ng/mL Geometric Coefficient of Variation 24.07	—	—	—	—	—	—	—	—	—	—
Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) and Soluble Terminal Complement Complex (sC5b-9) Biomarkers for Parts 1 and 2 to Day 90 Day 90 - Bb, n=17,16,17,25,21	90.5 ng/mL Geometric Coefficient of Variation 25.57	79.3 ng/mL Geometric Coefficient of Variation 22.47	77.6 ng/mL Geometric Coefficient of Variation 35.42	74.6 ng/mL Geometric Coefficient of Variation 23.91	102.7 ng/mL Geometric Coefficient of Variation 22.01	—	—	—	—	—	—	—	—	—	—
Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) and Soluble Terminal Complement Complex (sC5b-9) Biomarkers for Parts 1 and 2 to Day 90 Day 8 sC5B-9, n=12,16,13,22,17	80.6 ng/mL Geometric Coefficient of Variation 12.29	69.6 ng/mL Geometric Coefficient of Variation 37.40	65.9 ng/mL Geometric Coefficient of Variation 24.05	75.8 ng/mL Geometric Coefficient of Variation 30.15	95.2 ng/mL Geometric Coefficient of Variation 22.01	—	—	—	—	—	—	—	—	—	—
Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) and Soluble Terminal Complement Complex (sC5b-9) Biomarkers for Parts 1 and 2 to Day 90 Day 15 sC5B-9, n=13,14,16,21,21	79.4 ng/mL Geometric Coefficient of Variation 27.60	72.2 ng/mL Geometric Coefficient of Variation 33.86	78.4 ng/mL Geometric Coefficient of Variation 33.35	78.0 ng/mL Geometric Coefficient of Variation 32.06	99.4 ng/mL Geometric Coefficient of Variation 25.40	—	—	—	—	—	—	—	—	—	—
Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) and Soluble Terminal Complement Complex (sC5b-9) Biomarkers for Parts 1 and 2 to Day 90 Day 30 sC5B-9, n=16,17,18,25,24	85.8 ng/mL Geometric Coefficient of Variation 23.88	68.6 ng/mL Geometric Coefficient of Variation 41.32	76.4 ng/mL Geometric Coefficient of Variation 25.97	69.8 ng/mL Geometric Coefficient of Variation 21.98	94.2 ng/mL Geometric Coefficient of Variation 24.96	—	—	—	—	—	—	—	—	—	—
Change From Baseline in Plasma Levels of Circulating Fragment of Factor B (Bb) and Soluble Terminal Complement Complex (sC5b-9) Biomarkers for Parts 1 and 2 to Day 90 Day 90 sC5B-9, n=16,16,17,23,19	89.6 ng/mL Geometric Coefficient of Variation 28.66	73.8 ng/mL Geometric Coefficient of Variation 36.21	79.0 ng/mL Geometric Coefficient of Variation 22.82	75.0 ng/mL Geometric Coefficient of Variation 34.21	103.4 ng/mL Geometric Coefficient of Variation 21.52	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Month 3

Population: Full analysis set - all randomized patients with a baseline and at least one post-baseline value

The table shows the ratio to baseline in UPCR at Day 90 by treatment group. The lowest dose providing maximal reduction of proteinuria is the dose with the smallest UPCR ratio to baseline estimate (i.e. LNP023 200mg),

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=19 Participants 10 mg taken twice a day	LNP023 50 mg BID n=19 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=22 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=26 Participants 200 mg taken twice a day	Placebo n=25 Participants Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Estimation of the Lowest Dose Providing Maximal Reduction of Proteinuria as Measured by the Ratio to Baseline in UPCR at Day 90	0.85 Ratio to baseline Interval 0.77 to 0.93	0.80 Ratio to baseline Interval 0.73 to 0.87	0.76 Ratio to baseline Interval 0.7 to 0.81	0.69 Ratio to baseline Interval 0.61 to 0.77	0.88 Ratio to baseline Interval 0.8 to 1.0	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 180

Population: Full analysis set 2 - all randomized patients in study Part 2 that consented to receive treatment as per protocol version 04 or higher (i.e. 180 days of treatment)

eGFR; estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=9 Participants 10 mg taken twice a day	LNP023 50 mg BID n=10 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=19 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=11 Participants 200 mg taken twice a day	Placebo n=11 Participants Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Mixed Model of Repeated Measures (MMRM) of the Change From Baseline for Estimated Glomerular Filtration Rate (eGFR) - Part 2 up to Day 180	0.78 mL/min/SSA Standard Error 1.977	-2.35 mL/min/SSA Standard Error 1.995	-2.91 mL/min/SSA Standard Error 1.359	-1.18 mL/min/SSA Standard Error 1.798	-3.17 mL/min/SSA Standard Error 1.868	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 180

Population: Full analysis set 2 - all randomized patients in study Part 2 that consented to receive treatment as per protocol version 04 or higher (i.e. 180 days of treatment)

A midstream urine sample was obtained from the first morning void (FMV) on the visit day.

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=9 Participants 10 mg taken twice a day	LNP023 50 mg BID n=10 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=19 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=11 Participants 200 mg taken twice a day	Placebo n=11 Participants Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline Protein to Creatinine (UPCR) From 1st Morning Void - Part 2 up to Day 180	0.81 Ratio to baseline Interval 0.599 to 1.108	0.72 Ratio to baseline Interval 0.534 to 0.976	0.63 Ratio to baseline Interval 0.507 to 0.784	0.72 Ratio to baseline Interval 0.544 to 0.949	0.79 Ratio to baseline Interval 0.59 to 1.047	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 180

Population: Full analysis set - all randomized patients with both baseline and Day 180 hematuria values. The number of participants analyzed corresponds to the column totals (i.e. the number of patients with non-missing baseline and Day 180 values by hematuria level at Day 180 and treatment group).

Hematuria levels were the number of erythrocytes/high-power-field (hpf) measured through microscopic examination. The table shows the shift in hematuria grade (Low: \<9 rbc/hpf, Intermediate: \>=9 to \<= 50 rbc/hpf, High: \>50 rbc/hpf) from baseline (rows) to Day 180 (columns). A lower grade corresponds to a better outcome. Only patients with both baseline and Day 90 hematuria values are presented. L=low, I=intermediate and H=high in column headings for doses and BL=baseline

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=3 Participants 10 mg taken twice a day	LNP023 50 mg BID n=2 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 100 mg taken orally twice a day	LNP023 200 mg BID n=6 Participants 200 mg taken twice a day	Placebo Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L n=7 Participants L (\<9 rbc/hpf) at Day 90	100mg-I n=1 Participants I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L n=6 Participants L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L n=4 Participants L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H n=1 Participants H (\>50 rbc/hpf) at Day 90
Shift Table From Baseline for Hematuria Levels - Part 2 at Day 180 Low at baseline	1 participants	1 participants	—	5 participants	—	—	2 participants	0 participants	—	4 participants	—	—	4 participants	—	0 participants
Shift Table From Baseline for Hematuria Levels - Part 2 at Day 180 Intermediate at baseline	2 participants	1 participants	—	1 participants	—	—	3 participants	0 participants	—	2 participants	—	—	0 participants	—	1 participants
Shift Table From Baseline for Hematuria Levels - Part 2 at Day 180 High at baseline	0 participants	0 participants	—	0 participants	—	—	2 participants	1 participants	—	0 participants	—	—	0 participants	—	0 participants

SECONDARY outcome

Timeframe: Baseline, Days 30, 90 and 180

Population: Full analysis set 2 - all randomized patients in study Part 2 that consented to receive treatment as per protocol version 04 or higher (i.e. 180 days of treatment)

For UPCR test, participants collected all of their urine over a 24-hour period

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=9 Participants 10 mg taken twice a day	LNP023 50 mg BID n=10 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=19 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=11 Participants 200 mg taken twice a day	Placebo n=11 Participants Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Mixed Model of Repeated Measures (MMRM) of the Change From Baseline in Protein Level Urine Using the Urine Protein-creatinine Ratio (UPCR) From 24 Hour Urine Collection - Part 2 up to Day 180	1.06 mg/d Interval 0.803 to 1.394	0.59 mg/d Interval 0.452 to 0.779	0.66 mg/d Interval 0.54 to 0.798	0.73 mg/d Interval 0.568 to 0.94	0.91 mg/d Interval 0.705 to 1.185	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and Day 180

Population: Full analysis set 2 - all randomized patients in study Part 2 that consented to receive treatment as per protocol version 04 or higher (i.e. 180 days of treatment)

The 24-hour urine collection was started 1 day prior to the clinic visit, after participant urinated for the first time, than all urine was collected for the next 24 hours and refrigerated prior to clinic visit.

Outcome measures

Outcome measures
Measure	LNP023 10 mg BID n=9 Participants 10 mg taken twice a day	LNP023 50 mg BID n=10 Participants 50 mg taken twice a day	LNP023 100 mg BID - Part 2 n=19 Participants 100 mg taken orally twice a day	LNP023 200 mg BID n=11 Participants 200 mg taken twice a day	Placebo n=11 Participants Placebo identical to LNP023 taken orally twice a day	50mg-H H (\>50 rbc/hpf) at Day 90	100mg-L L (\<9 rbc/hpf) at Day 90	100mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	100mg-H H (\>50 rbc/hpf) at Day 90	200mg-L L (\<9 rbc/hpf) at Day 90	200mg-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	200mg-H H (\>50 rbc/hpf) at Day 90	Pl-L L (\<9 rbc/hpf) at Day 90	PL-I I (\>=9 to \<= 50 rbc/hpf) at Day 90	PL-H H (\>50 rbc/hpf) at Day 90
Mixed Model of Repeated Measures (MMRM) of the Ratio to Baseline in 24 Hour Urine Albumin to Creatinine (UACR) - Part 2 up to Day 180	1.04 Ratio to baseline Interval 0.779 to 1.392	0.61 Ratio to baseline Interval 0.454 to 0.808	0.65 Ratio to baseline Interval 0.526 to 0.792	0.69 Ratio to baseline Interval 0.533 to 0.902	0.91 Ratio to baseline Interval 0.696 to 1.2	—	—	—	—	—	—	—	—	—	—

Adverse Events

LNP023 10mg On-treatment

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

LNP023 50mg On-treatment

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

LNP023 100mg On-treatment

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

LNP023 200mg On-treatment

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo On-treatment

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

LNP023 10mg Follow-up

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

LNP023 50mg Follow-up

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

LNP023 100mg Follow-up

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

LNP023 200mg Follow-up

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo Follow-up

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LNP023 10mg On-treatment n=20 participants at risk LNP023 10mg On-treatment	LNP023 50mg On-treatment n=19 participants at risk LNP023 50mg On-treatment	LNP023 100mg On-treatment n=22 participants at risk LNP023 100mg On-treatment	LNP023 200mg On-treatment n=26 participants at risk LNP023 200mg On-treatment	Placebo On-treatment n=25 participants at risk Placebo On-treatment	LNP023 10mg Follow-up n=20 participants at risk LNP023 10mg safety follow-up	LNP023 50mg Follow-up n=19 participants at risk LNP023 50mg follow-up	LNP023 100mg Follow-up n=22 participants at risk LNP023 100mg follow-up	LNP023 200mg Follow-up n=26 participants at risk LNP023 200mg follow-up	Placebo Follow-up n=25 participants at risk Placebo follow-up
Infections and infestations Appendicitis	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations COVID-19	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Influenza	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polycythaemia vera	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Renal and urinary disorders Renal impairment	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.

Other adverse events

Other adverse events
Measure	LNP023 10mg On-treatment n=20 participants at risk LNP023 10mg On-treatment	LNP023 50mg On-treatment n=19 participants at risk LNP023 50mg On-treatment	LNP023 100mg On-treatment n=22 participants at risk LNP023 100mg On-treatment	LNP023 200mg On-treatment n=26 participants at risk LNP023 200mg On-treatment	Placebo On-treatment n=25 participants at risk Placebo On-treatment	LNP023 10mg Follow-up n=20 participants at risk LNP023 10mg safety follow-up	LNP023 50mg Follow-up n=19 participants at risk LNP023 50mg follow-up	LNP023 100mg Follow-up n=22 participants at risk LNP023 100mg follow-up	LNP023 200mg Follow-up n=26 participants at risk LNP023 200mg follow-up	Placebo Follow-up n=25 participants at risk Placebo follow-up
Investigations Blood creatine phosphokinase increased	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Investigations Blood creatinine increased	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Cardiac disorders Bundle branch block right	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Injury, poisoning and procedural complications Vaccination complication	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	9.1% 2/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Investigations Amylase increased	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Blood and lymphatic system disorders Anaemia	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Cardiac disorders Palpitations	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Cardiac disorders Sinus bradycardia	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Cardiac disorders Tachycardia	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Cardiac disorders Wolff-Parkinson-White syndrome	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Ear and labyrinth disorders Vertigo	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Eye disorders Asthenopia	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Eye disorders Dry eye	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	15.8% 3/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	9.1% 2/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Abdominal distension	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Abdominal pain	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Abdominal pain lower	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Abdominal pain upper	10.0% 2/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Aphthous ulcer	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Diarrhoea	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	10.5% 2/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	12.0% 3/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Dyspepsia	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Food poisoning	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Gastrooesophageal reflux disease	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Mouth haemorrhage	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Mouth ulceration	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Nausea	15.0% 3/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Tooth disorder	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Toothache	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Gastrointestinal disorders Vomiting	15.0% 3/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	10.5% 2/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
General disorders Asthenia	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
General disorders Chest pain	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
General disorders Face oedema	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
General disorders Fatigue	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	10.5% 2/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	12.0% 3/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
General disorders Feeling hot	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
General disorders Influenza like illness	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
General disorders Oedema	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
General disorders Oedema peripheral	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
General disorders Pain	10.0% 2/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
General disorders Pyrexia	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	10.5% 2/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Asymptomatic bacteriuria	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Bronchitis	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations COVID-19	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Conjunctivitis	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Gastroenteritis	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	9.1% 2/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Gingivitis	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Hordeolum	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Influenza	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Nasopharyngitis	10.0% 2/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	10.5% 2/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	8.0% 2/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	10.5% 2/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Norovirus infection	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Onychomycosis	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Oral herpes	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Otitis externa	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Otitis media	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Pharyngitis	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Respiratory tract infection	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Tonsillitis	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Tooth abscess	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Tracheobronchitis	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Upper respiratory tract infection	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Urinary tract infection	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Infections and infestations Viral infection	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Injury, poisoning and procedural complications Overdose	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Investigations Blood potassium increased	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Investigations Blood pressure increased	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Investigations Blood testosterone decreased	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Investigations Blood triglycerides increased	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Investigations Coagulation test abnormal	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Investigations Cystatin C increased	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Investigations Glomerular filtration rate decreased	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Investigations Lipase increased	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Investigations Pancreatic enzymes increased	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Investigations SARS-CoV-2 test negative	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	9.1% 2/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Investigations Weight increased	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Investigations White blood cell count increased	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Metabolism and nutrition disorders Gout	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Metabolism and nutrition disorders Hypercholesterolaemia	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	8.0% 2/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Metabolism and nutrition disorders Iron deficiency	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Metabolism and nutrition disorders Obesity	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Metabolism and nutrition disorders Vitamin B12 deficiency	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Skin and subcutaneous tissue disorders Eczema nummular	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 2/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	9.1% 2/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Musculoskeletal and connective tissue disorders Back pain	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	13.6% 3/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	12.0% 3/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	9.1% 2/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Musculoskeletal and connective tissue disorders Polyarthritis	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Essential thrombocythaemia	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polycythaemia vera	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Nervous system disorders Disturbance in attention	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	9.1% 2/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Nervous system disorders Dizziness	10.0% 2/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	15.8% 3/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Nervous system disorders Dysaesthesia	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Nervous system disorders Epilepsy	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Nervous system disorders Head discomfort	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Nervous system disorders Headache	10.0% 2/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	10.5% 2/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	9.1% 2/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	7.7% 2/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	24.0% 6/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Nervous system disorders Migraine	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Nervous system disorders Syncope	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Nervous system disorders Taste disorder	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Skin and subcutaneous tissue disorders Erythema	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Nervous system disorders Tremor	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Psychiatric disorders Depression	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Psychiatric disorders Insomnia	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Renal and urinary disorders Acute kidney injury	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Renal and urinary disorders Dysuria	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Renal and urinary disorders Haematuria	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Renal and urinary disorders IgA nephropathy	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Renal and urinary disorders Proteinuria	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Renal and urinary disorders Renal pain	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Renal and urinary disorders Renal vasculitis	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Reproductive system and breast disorders Dysmenorrhoea	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	9.1% 2/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	8.0% 2/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	10.5% 2/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Respiratory, thoracic and mediastinal disorders Throat irritation	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Skin and subcutaneous tissue disorders Acne	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Skin and subcutaneous tissue disorders Dermatosis	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Skin and subcutaneous tissue disorders Eczema	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	3.8% 1/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Skin and subcutaneous tissue disorders Rash	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Skin and subcutaneous tissue disorders Vasculitic rash	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Vascular disorders Hot flush	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Vascular disorders Hypertension	5.0% 1/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	5.3% 1/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.0% 1/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	4.5% 1/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.
Vascular disorders Hypotension	15.0% 3/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	7.7% 2/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/20 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/19 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/22 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/26 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.	0.00% 0/25 • Adverse events were reported from first dose to end of study treatment (tx) plus 7 days post tx. Maximum reporting time for Treatment Emergent Adverse Events was: Part 1=99 days, Part II: 197 days. There was an additional 90 day safety follow up period for both periods.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: + 1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER