Trial Outcomes & Findings for A Study of SB-743921 in Non-Hodgkin Lymphoma and Hodgkin Lymphoma (NCT NCT00343564)

NCT ID: NCT00343564

Last Updated: 2020-01-13

Results Overview

Maximum Tolerated Dose (MTD) was determined by testing increasing doses in cohorts with at least 3 patients each. MTD reflects the highest dose of drug that did not cause dose limiting toxicity (DLT).

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 68 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2020-01-13

Participant Flow

Participant milestones

Measure	2 mg/m2 Without GCSF Phase 1 dose escalation cohort 1 without GCSF support	3 mg/m2 Without GCSF Phase 1 dose escalation cohort 2 without GCSF support	4 mg/m2 Without GCSF Phase 1 dose escalation cohort 3 without GCSF support	5 mg/m2 Without GCSF Phase 1 dose escalation cohort 4 without GCSF support	6 mg/m2 Without GCSF Phase 1 dose escalation cohort 5 without GCSF support	7 mg/m2 Without GCSF Phase 1 dose escalation cohort 6 without GCSF support	6 mg/m2 With GCSF Phase 1 dose escalation cohort 1 with GCSF support	7 mg/m2 With GCSF Phase 1 dose escalation cohort 2 with GCSF support	8 mg/m2 With GCSF Phase 1 dose escalation cohort 3 with GCSF support	9 mg/m2 With GCSF Phase 1 dose escalation cohort 4 with GCSF support	10 mg/m2 With GCSF Phase 1 dose escalation cohort 5 with GCSF support
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Overall Study STARTED	6	7	3	7	10	9	4	3	3	8	8
Overall Study COMPLETED	6	7	3	7	10	9	4	3	3	8	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of SB-743921 in Non-Hodgkin Lymphoma and Hodgkin Lymphoma

Baseline characteristics by cohort

Measure	2 mg/m2 Without GCSF n=6 Participants Phase 1 dose escalation cohort 1 without GCSF support	3 mg/m2 Without GCSF n=7 Participants Phase 1 dose escalation cohort 2 without GCSF support	4 mg/m2 Without GCSF n=3 Participants Phase 1 dose escalation cohort 3 without GCSF support	5 mg/m2 Without GCSF n=7 Participants Phase 1 dose escalation cohort 4 without GCSF support	6 mg/m2 Without GCSF n=10 Participants Phase 1 dose escalation cohort 5 without GCSF support	7 mg/m2 Without GCSF n=9 Participants Phase 1 dose escalation cohort 6 without GCSF support	6 mg/m2 With GCSF n=4 Participants Phase 1 dose escalation cohort 1 with GCSF support	7 mg/m2 With GCSF n=3 Participants Phase 1 dose escalation cohort 2 with GCSF support	8 mg/m2 With GCSF n=3 Participants Phase 1 dose escalation cohort 3 with GCSF support	9 mg/m2 With GCSF n=8 Participants Phase 1 dose escalation cohort 4 with GCSF support	10 mg/m2 With GCSF n=8 Participants Phase 1 dose escalation cohort 5 with GCSF support	Total n=68 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	8 Participants n=21 Participants	6 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	43 Participants n=42 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	4 Participants n=42 Participants	4 Participants n=42 Participants	24 Participants n=42 Participants
Age, Continuous	62 years STANDARD_DEVIATION 9 • n=5 Participants	43 years STANDARD_DEVIATION 13 • n=7 Participants	33 years STANDARD_DEVIATION 9 • n=5 Participants	57 years STANDARD_DEVIATION 22 • n=4 Participants	48 years STANDARD_DEVIATION 16 • n=21 Participants	42 years STANDARD_DEVIATION 24 • n=8 Participants	69 years STANDARD_DEVIATION 12 • n=8 Participants	63 years STANDARD_DEVIATION 11 • n=24 Participants	63 years STANDARD_DEVIATION 17 • n=42 Participants	48 years STANDARD_DEVIATION 22 • n=42 Participants	56 years STANDARD_DEVIATION 20 • n=42 Participants	52 years STANDARD_DEVIATION 19 • n=42 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	29 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=8 Participants	2 Participants n=8 Participants	2 Participants n=24 Participants	2 Participants n=42 Participants	5 Participants n=42 Participants	7 Participants n=42 Participants	39 Participants n=42 Participants
Region of Enrollment United States	6 participants n=5 Participants	4 participants n=7 Participants	1 participants n=5 Participants	5 participants n=4 Participants	7 participants n=21 Participants	6 participants n=8 Participants	4 participants n=8 Participants	3 participants n=24 Participants	2 participants n=42 Participants	8 participants n=42 Participants	7 participants n=42 Participants	53 participants n=42 Participants
Region of Enrollment Russian Federation	0 participants n=5 Participants	3 participants n=7 Participants	2 participants n=5 Participants	2 participants n=4 Participants	3 participants n=21 Participants	3 participants n=8 Participants	0 participants n=8 Participants	0 participants n=24 Participants	1 participants n=42 Participants	0 participants n=42 Participants	1 participants n=42 Participants	15 participants n=42 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Safety population; all patients who received at least 1 dose of study drug were included in the intent-to-treat/safety populations. Efficacy evaluable; any patient who received both cycles of treatment.

Maximum Tolerated Dose (MTD) was determined by testing increasing doses in cohorts with at least 3 patients each. MTD reflects the highest dose of drug that did not cause dose limiting toxicity (DLT).

Outcome measures

Measure	Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF) n=4 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF) n=5 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 5 6 mg/m2 (w/o GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 6 7 mg/m2 (w/o GCSF) n=9 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 1 6 mg/m2 (w/ GCSF) n=4 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 2 7mg/m2 (w/GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 3 8 mg/m2 (w/GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 4 9 mg/m2 (w/GCSF) n=7 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 5 10 mg/m2 (w/GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support
Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF.	2 mg/m2	3 mg/m2	4 mg/m2	5 mg/m2	6 mg/m2	6 mg/m2	6 mg/m2	7 mg/m2	8 mg/m2	9 mg/m2	9 mg/m2

SECONDARY outcome

Timeframe: Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Outcome measures

Measure	Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF) n=5 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 5 6 mg/m2 (w/o GCSF) n=13 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 6 7 mg/m2 (w/o GCSF) n=12 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 1 6 mg/m2 (w/ GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 2 7mg/m2 (w/GCSF) n=7 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 3 8 mg/m2 (w/GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 4 9 mg/m2 (w/GCSF) Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 5 10 mg/m2 (w/GCSF) Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support
Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1	172 ng/mL Standard Deviation 40.7	348 ng/mL Standard Deviation 86.6	357 ng/mL Standard Deviation 50.4	514 ng/mL Standard Deviation 177	600 ng/mL Standard Deviation 175	689 ng/mL Standard Deviation 401	1130 ng/mL Standard Deviation 189	805 ng/mL Standard Deviation 501	1180 ng/mL Standard Deviation 682	—	—

SECONDARY outcome

Timeframe: Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Outcome measures

Measure	Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF) n=5 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 5 6 mg/m2 (w/o GCSF) n=13 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 6 7 mg/m2 (w/o GCSF) n=12 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 1 6 mg/m2 (w/ GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 2 7mg/m2 (w/GCSF) n=7 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 3 8 mg/m2 (w/GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 4 9 mg/m2 (w/GCSF) Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 5 10 mg/m2 (w/GCSF) Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support
Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day1	1.20 hr Standard Deviation 0.45	1.00 hr Standard Deviation 0.00	1.00 hr Standard Deviation 0.00	1.00 hr Standard Deviation 0.00	1.08 hr Standard Deviation 0.28	1.00 hr Standard Deviation 0.43	1.00 hr Standard Deviation 0.00	1.00 hr Standard Deviation 0.00	1.17 hr Standard Deviation 0.41	—	—

SECONDARY outcome

Timeframe: Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Outcome measures

Measure	Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF) n=5 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 5 6 mg/m2 (w/o GCSF) n=13 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 6 7 mg/m2 (w/o GCSF) n=12 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 1 6 mg/m2 (w/ GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 2 7mg/m2 (w/GCSF) n=7 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 3 8 mg/m2 (w/GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 4 9 mg/m2 (w/GCSF) Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 5 10 mg/m2 (w/GCSF) Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support
Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1	36.9 ng/mL Standard Deviation 23.6	61.6 ng/mL Standard Deviation 29.4	59.5 ng/mL Standard Deviation 39.9	79.1 ng/mL Standard Deviation 51.9	133 ng/mL Standard Deviation 64.7	103 ng/mL Standard Deviation 48.3	144 ng/mL Standard Deviation 97.6	122 ng/mL Standard Deviation 69.6	245 ng/mL Standard Deviation 134	—	—

SECONDARY outcome

Timeframe: Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Outcome measures

Measure	Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF) n=5 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 5 6 mg/m2 (w/o GCSF) n=13 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 6 7 mg/m2 (w/o GCSF) n=12 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 1 6 mg/m2 (w/ GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 2 7mg/m2 (w/GCSF) n=7 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 3 8 mg/m2 (w/GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 4 9 mg/m2 (w/GCSF) Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 5 10 mg/m2 (w/GCSF) Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support
Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 1	1807 hr*ng/mL Standard Deviation 1104	2800 hr*ng/mL Standard Deviation 988.6	3269 hr*ng/mL Standard Deviation 950.2	3707 hr*ng/mL Standard Deviation 1750	5838 hr*ng/mL Standard Deviation 2588	5359 hr*ng/mL Standard Deviation 3028	6270 hr*ng/mL Standard Deviation 2751	5875 hr*ng/mL Standard Deviation 3483	11570 hr*ng/mL Standard Deviation 6318	—	—

SECONDARY outcome

Timeframe: Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Outcome measures

Measure	Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF) n=5 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF) n=8 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 5 6 mg/m2 (w/o GCSF) n=13 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 6 7 mg/m2 (w/o GCSF) n=8 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 1 6 mg/m2 (w/ GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 2 7mg/m2 (w/GCSF) n=7 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 3 8 mg/m2 (w/GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 4 9 mg/m2 (w/GCSF) Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 5 10 mg/m2 (w/GCSF) Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support
Characterization of PK (Cmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15	220 ng/mL Standard Deviation 51.2	323 ng/mL Standard Deviation 120	365 ng/mL Standard Deviation 45.2	599 ng/mL Standard Deviation 383	717 ng/mL Standard Deviation 278	835 ng/mL Standard Deviation 442	685 ng/mL Standard Deviation 163	706 ng/mL Standard Deviation 344	1430 ng/mL Standard Deviation 1620	—	—

SECONDARY outcome

Timeframe: Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Outcome measures

Measure	Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF) n=5 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF) n=8 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 5 6 mg/m2 (w/o GCSF) n=13 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 6 7 mg/m2 (w/o GCSF) n=8 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 1 6 mg/m2 (w/ GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 2 7mg/m2 (w/GCSF) n=7 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 3 8 mg/m2 (w/GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 4 9 mg/m2 (w/GCSF) Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 5 10 mg/m2 (w/GCSF) Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support
Characterization of PK (Tmax) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15	1.00 hr Standard Deviation 0.00	1.00 hr Standard Deviation 0.00	1.00 hr Standard Deviation 0.00	1.00 hr Standard Deviation 0.00	1.00 hr Standard Deviation 0.00	1.00 hr Standard Deviation 0.00	1.00 hr Standard Deviation 0.00	1.00 hr Standard Deviation 0.00	1.00 hr Standard Deviation 0.00	—	—

SECONDARY outcome

Timeframe: Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Outcome measures

Measure	Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF) n=5 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF) n=8 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 5 6 mg/m2 (w/o GCSF) n=13 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 6 7 mg/m2 (w/o GCSF) n=8 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 1 6 mg/m2 (w/ GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 2 7mg/m2 (w/GCSF) n=7 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 3 8 mg/m2 (w/GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 4 9 mg/m2 (w/GCSF) Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 5 10 mg/m2 (w/GCSF) Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support
Characterization of PK (Clast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15	29.2 ng/mL Standard Deviation 11.8	84.2 ng/mL Standard Deviation 60.8	58.5 ng/mL Standard Deviation 29.8	84.6 ng/mL Standard Deviation 47.9	138 ng/mL Standard Deviation 103	92.4 ng/mL Standard Deviation 50.5	138 ng/mL Standard Deviation 94.9	150 ng/mL Standard Deviation 105	285 ng/mL Standard Deviation 290	—	—

SECONDARY outcome

Timeframe: Pre-dose, immediately post-dose, between 2 and 4 hours post-dose and between 24 and 36 hours post-dose

Outcome measures

Measure	Dose Escalation Cohort 1 2 mg/m2 (w/o GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 2 3 mg/m2 (w/o GCSF) n=5 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 3 4 mg/m2 (w/o GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 4 5 mg/m2 (w/o GCSF) n=8 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 5 6 mg/m2 (w/o GCSF) n=13 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 6 7 mg/m2 (w/o GCSF) n=8 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support	Dose Escalation Cohort 1 6 mg/m2 (w/ GCSF) n=3 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 2 7mg/m2 (w/GCSF) n=7 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 3 8 mg/m2 (w/GCSF) n=6 Participants Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 4 9 mg/m2 (w/GCSF) Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support	Dose Escalation Cohort 5 10 mg/m2 (w/GCSF) Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support
Characterization of PK (AUClast) of SB-743921 Administered as a 1-hour Intravenous Infusion on Day 15	1809 hr*ng/mL Standard Deviation 464.1	2363 hr*ng/mL Standard Deviation 1187	3380 hr*ng/mL Standard Deviation 1456	4105 hr*ng/mL Standard Deviation 2190	5869 hr*ng/mL Standard Deviation 3417	5116 hr*ng/mL Standard Deviation 1728	6041 hr*ng/mL Standard Deviation 3010	6178 hr*ng/mL Standard Deviation 3630	12590 hr*ng/mL Standard Deviation 17850	—	—

Adverse Events

2 mg/m2 Without GCSF

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

3 mg/m2 Without GCSF

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

4 mg/m2 Without GCSF

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

5 mg/m2 Without GCSF

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

6 mg/m2 Without GCSF

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

7 mg/m2 Without GCSF

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

6 mg/m2 With GCSF

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

7 mg/m2 With GCSF

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

8 mg/m2 With GCSF

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

9 mg/m2 With GCSF

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

10 mg/m2 With GCSF

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	2 mg/m2 Without GCSF n=5 participants at risk Phase 1 dose escalation cohort 1 without GCSF support	3 mg/m2 Without GCSF n=6 participants at risk Phase 1 dose escalation cohort 2 without GCSF support	4 mg/m2 Without GCSF n=3 participants at risk Phase 1 dose escalation cohort 3 without GCSF support	5 mg/m2 Without GCSF n=6 participants at risk Phase 1 dose escalation cohort 4 without GCSF support	6 mg/m2 Without GCSF n=10 participants at risk Phase 1 dose escalation cohort 5 without GCSF support	7 mg/m2 Without GCSF n=9 participants at risk Phase 1 dose escalation cohort 6 without GCSF support	6 mg/m2 With GCSF n=4 participants at risk Phase 1 dose escalation cohort 1 with GCSF support	7 mg/m2 With GCSF n=3 participants at risk Phase 1 dose escalation cohort 2 with GCSF support	8 mg/m2 With GCSF n=3 participants at risk Phase 1 dose escalation cohort 3 with GCSF support	9 mg/m2 With GCSF n=7 participants at risk Phase 1 dose escalation cohort 4 with GCSF support	10 mg/m2 With GCSF n=7 participants at risk Phase 1 dose escalation cohort 5 with GCSF support
Infections and infestations Clostridium infection	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Sepsis	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Enterobacter bacteraemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Pneumococcal bacteraemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Pneumonia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Staphyloccal infection	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Blood and lymphatic system disorders Neutropenia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Blood and lymphatic system disorders Anaemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Blood and lymphatic system disorders Haemolytic anaemia	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Heparin-induced thrombocytopenia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Sudden death	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Renal and urinary disorders Haematuria	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Renal and urinary disorders Renal failure acute	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Cardiac disorders Atrial fibrillation	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Injury, poisoning and procedural complications Procedural hypotension	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant plural effusion	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.

Other adverse events

Measure	2 mg/m2 Without GCSF n=5 participants at risk Phase 1 dose escalation cohort 1 without GCSF support	3 mg/m2 Without GCSF n=6 participants at risk Phase 1 dose escalation cohort 2 without GCSF support	4 mg/m2 Without GCSF n=3 participants at risk Phase 1 dose escalation cohort 3 without GCSF support	5 mg/m2 Without GCSF n=6 participants at risk Phase 1 dose escalation cohort 4 without GCSF support	6 mg/m2 Without GCSF n=10 participants at risk Phase 1 dose escalation cohort 5 without GCSF support	7 mg/m2 Without GCSF n=9 participants at risk Phase 1 dose escalation cohort 6 without GCSF support	6 mg/m2 With GCSF n=4 participants at risk Phase 1 dose escalation cohort 1 with GCSF support	7 mg/m2 With GCSF n=3 participants at risk Phase 1 dose escalation cohort 2 with GCSF support	8 mg/m2 With GCSF n=3 participants at risk Phase 1 dose escalation cohort 3 with GCSF support	9 mg/m2 With GCSF n=7 participants at risk Phase 1 dose escalation cohort 4 with GCSF support	10 mg/m2 With GCSF n=7 participants at risk Phase 1 dose escalation cohort 5 with GCSF support
Blood and lymphatic system disorders Anaemia	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	40.0% 4/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	22.2% 2/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	50.0% 2/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	71.4% 5/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Blood and lymphatic system disorders Leukopenia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	20.0% 2/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	50.0% 2/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Blood and lymphatic system disorders Neutropenia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	83.3% 5/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	50.0% 5/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	77.8% 7/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	75.0% 3/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	100.0% 3/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	57.1% 4/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	71.4% 5/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Blood and lymphatic system disorders Thrombocytopenia	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 2/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	22.2% 2/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	50.0% 2/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	66.7% 2/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	42.9% 3/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	71.4% 5/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Cardiac disorders Atrial fibrillation	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Cardiac disorders Tachycardia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 2/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	20.0% 2/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	42.9% 3/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	22.2% 2/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	66.7% 2/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	42.9% 3/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	22.2% 2/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Skin and subcutaneous tissue disorders Alopecia	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Skin and subcutaneous tissue disorders Dry skin	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	22.2% 2/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Skin and subcutaneous tissue disorders Palmar erythema	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	22.2% 2/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Skin and subcutaneous tissue disorders Rash	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Skin and subcutaneous tissue disorders Urticaria	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Vascular disorders Phlebitis	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Vascular disorders Thrombosis	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Vascular disorders Vein discolouration	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Ear and labyrinth disorders Hypoacusis	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Eye disorders Conjunctival haemorrhage	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Eye disorders Vision blurred	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Eye disorders Visual disturbance	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Abdominal discomfort	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Abdominal distension	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	22.2% 2/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Abdominal pain	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 2/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Constipation	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	57.1% 4/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Diarrhoea	40.0% 2/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 2/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Dry mouth	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Dyspepsia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Dysphagia	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Gastritis	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Lip ulceration	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Nausea	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 2/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	30.0% 3/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Stomach discomfort	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Stomatitis	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Gastrointestinal disorders Vomiting	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Asthenia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	20.0% 2/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Chest discomfort	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Chest pain	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Chills	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Fatigue	60.0% 3/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 2/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	66.7% 2/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	44.4% 4/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	100.0% 3/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	42.9% 3/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	71.4% 5/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Gait disturbance	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Malaise	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Oedema	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Oedema peripheral	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Pain	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Performance status decreased	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	20.0% 2/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Peripheral coldness	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Pyrexia	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 2/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	20.0% 2/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 3/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	71.4% 5/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Suprapubic pain	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
General disorders Thirst	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Immune system disorders Drug hypersensitivity	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Bronchitis	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Herpes simplex	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Herpes virus infection	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Herpes zoster	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Respiratory tract infection	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Respiratory tract infection viral	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Rhinitis	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Sinusitis	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Skin infection	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Tooth infection	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 2/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Urinary tract infection	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Injury, poisoning and procedural complications Incision site complication	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Injury, poisoning and procedural complications Sunburn	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Injury, poisoning and procedural complications Tracheal obstruction	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Investigations Alanine aminotransferase increased	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Investigations Aspartate aminotransferase increased	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	22.2% 2/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Investigations Blood alkaline phosphatase increased	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Investigations Blood bicarbonate decreased	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Investigations Blood creatinine increased	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Investigations C-reactive protein increased	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Investigations Electrocardiogram QT corrected interval prolonged	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Investigations Gamma-glutamyltransferase increased	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Investigations Urine colour abnormal	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Investigations Urine output decreased	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Investigations Weight decreased	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Acidosis	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Anorexia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	22.2% 2/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	42.9% 3/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Cachexia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Hyperglycaemia	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	40.0% 4/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	66.7% 2/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	20.0% 2/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	30.0% 3/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Metabolism and nutrition disorders Polydipsia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 2/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	20.0% 2/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	66.7% 2/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Musculoskeletal and connective tissue disorders Bone pain	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Musculoskeletal and connective tissue disorders Sacral pain	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Musculoskeletal and connective tissue disorders Shoulder pain	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Nervous system disorders Dizziness	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	28.6% 2/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Nervous system disorders Dysarthria	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Nervous system disorders Dysgeusia	40.0% 2/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Nervous system disorders Headache	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	22.2% 2/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Nervous system disorders Hypoaesthesia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Nervous system disorders Neuropathy	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Nervous system disorders Neuropathy peripheral	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Nervous system disorders Paraesthesia	40.0% 2/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Nervous system disorders Parosmia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Nervous system disorders Sinus headache	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Nervous system disorders Somnolence	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Psychiatric disorders Anxiety	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Psychiatric disorders Depression	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Psychiatric disorders Insomnia	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Psychiatric disorders Libido decreased	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	25.0% 1/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Psychiatric disorders Mental status changes	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	10.0% 1/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Renal and urinary disorders Dysuria	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Renal and urinary disorders Neurogenic bladder	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	14.3% 1/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Renal and urinary disorders Pollakiuria	20.0% 1/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Renal and urinary disorders Polyuria	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	11.1% 1/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	33.3% 1/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/5 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	16.7% 1/6 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/10 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/9 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/4 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/3 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.	0.00% 0/7 • Adverse events were collected during the 28-day treatment period and at a 14-day follow up visit. Patients who received at least 1 dose of treatment were considered eligible for safety.

Additional Information

Project Manager

Cytokinetics,Inc.

Phone: 650-624-2918

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor intends to publish the results of the trial in collaboration with the Investigators.
• Publication restrictions are in place

Restriction type: OTHER