Trial Outcomes & Findings for Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism (NCT NCT02730169)

Last Updated: 2022-09-14

Results Overview

Percentage of patients with normalised testosterone i.e. testosterone in the range 300-1000ng/dL after 24 weeks of study treatment. The primary objective was considered met, if greater than or equal to 75% of the participants in any arm normalised.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

271 participants

Primary outcome timeframe

24 weeks of treatment

Results posted on

2022-09-14

Participant Flow

Participant milestones

Participant milestones
Measure	BGS649 0.1 mg BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Overall Study STARTED	67	66	67	71
Overall Study COMPLETED	53	45	50	55
Overall Study NOT COMPLETED	14	21	17	16

Reasons for withdrawal

Reasons for withdrawal
Measure	BGS649 0.1 mg BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Overall Study Protocol Violation	1	0	0	1
Overall Study Adverse Event	2	3	3	0
Overall Study Adverse Event of Special Interest	0	1	2	0
Overall Study Withdrawal by Subject	6	11	6	8
Overall Study Lost to Follow-up	5	6	5	6
Overall Study Other	0	0	1	1

Baseline Characteristics

Safety and Efficacy of BGS649 in Male Obese Subjects With Hypogonadotropic Hypogonadism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BGS649 0.1 mg n=67 Participants BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=66 Participants BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=67 Participants BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo n=71 Participants Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks	Total n=271 Participants Total of all reporting groups
Race (NIH/OMB) White	53 Participants n=5 Participants	49 Participants n=7 Participants	49 Participants n=5 Participants	61 Participants n=4 Participants	212 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	51.4 years STANDARD_DEVIATION 8.39 • n=5 Participants	51.6 years STANDARD_DEVIATION 7.31 • n=7 Participants	49.6 years STANDARD_DEVIATION 9.72 • n=5 Participants	50.9 years STANDARD_DEVIATION 9.17 • n=4 Participants	50.8 years STANDARD_DEVIATION 8.69 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	66 Participants n=7 Participants	67 Participants n=5 Participants	71 Participants n=4 Participants	271 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants	7 Participants n=4 Participants	47 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants

PRIMARY outcome

Timeframe: 24 weeks of treatment

Population: ITT Population

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=67 Participants BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=65 Participants BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=67 Participants BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo n=71 Participants Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Percentage of Patients With Normalised Testosterone After 24 Weeks of Study Treatment	59 Participants	62 Participants	63 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

Population: ITT Population

Normalised total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels \>1000 ng/dL were considered super-physiological outside the normal range.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=67 Participants BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=65 Participants BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=67 Participants BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo n=71 Participants Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 Baseline	7 Participants	12 Participants	11 Participants	7 Participants
The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 Visit 2 (Day 8)	54 Participants	53 Participants	57 Participants	7 Participants
The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 Visit 3 (Week 4)	63 Participants	62 Participants	64 Participants	10 Participants
The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 Visit 4 (Week 8)	63 Participants	61 Participants	65 Participants	11 Participants
The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 Visit 5 (Week 12)	58 Participants	62 Participants	64 Participants	7 Participants
The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 Visit 6 (Week 16)	57 Participants	63 Participants	63 Participants	8 Participants
The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 Visit 7 (Week 20)	57 Participants	63 Participants	66 Participants	9 Participants
The Proportion of Subjects That Have Normalization of Total Testosterone Serum Concentrations From Baseline to Week 24 Visit 8 (Week 24)	59 Participants	62 Participants	63 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

Population: ITT population

Testosterone overshoot was defined as total testosterone above 1000 ng/dL (35 nmol/L). Samples were collected in the morning before 11 am pre dose.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=67 Participants BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=65 Participants BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=67 Participants BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo n=71 Participants Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 Baseline	0 Participants	0 Participants	0 Participants	0 Participants
Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 Visit 3 (Week 4)	0 Participants	0 Participants	0 Participants	0 Participants
Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 Visit 4 (Week 8)	0 Participants	0 Participants	1 Participants	0 Participants
Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 Visit 5 (Week 12)	0 Participants	0 Participants	2 Participants	2 Participants
Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 Visit 6 (Week 16)	0 Participants	0 Participants	2 Participants	1 Participants
Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 Visit 7 (Week 20)	0 Participants	0 Participants	0 Participants	1 Participants
Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 Visit 8 (Week 24)	0 Participants	0 Participants	1 Participants	0 Participants
Proportion of Subjects That Overshoot Testosterone (Total Testosterone Above 1000 ng/dL [35 Nmol/L]) From Baseline to Week 24 Visit 2 (Day 8)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 weeks of treatment

Population: ITT Population

Normalized total testosterone level was defined as between 300-1000 ng/dL (10.4-35 nmol/L) inclusive. Levels \>1000 ng/dL were considered super-physiological outside the normal range. This secondary outcome measure was considered to have been met for a dose if ≥ 90% of subjects in the intent-to-treat (ITT) population had normalisation of total testosterone levels at Week 24.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=67 Participants BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=65 Participants BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=67 Participants BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo n=71 Participants Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Normalization of Total Testosterone Serum Concentrations in ≥ 90% Subjects After 24 Weeks of Treatment.	59 Participants	62 Participants	63 Participants	7 Participants

SECONDARY outcome

Timeframe: Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

Population: ITT Population

LH was measured at screening, baseline. The Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=67 Participants BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=65 Participants BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=67 Participants BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo n=71 Participants Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. Visit 2 (Day 8)	1.680 mIU/mL Standard Deviation 1.7503	2.095 mIU/mL Standard Deviation 1.3719	3.309 mIU/mL Standard Deviation 1.8200	-0.183 mIU/mL Standard Deviation 1.3531
Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. Visit 3 (Week 4)	2.237 mIU/mL Standard Deviation 2.1982	3.626 mIU/mL Standard Deviation 2.6519	5.235 mIU/mL Standard Deviation 4.8684	-0.385 mIU/mL Standard Deviation 1.2423
Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. Visit 4 (Week 8)	2.272 mIU/mL Standard Deviation 2.1908	3.653 mIU/mL Standard Deviation 3.0907	5.676 mIU/mL Standard Deviation 4.1471	-0.169 mIU/mL Standard Deviation 1.5237
Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. Visit 5 (Week 12)	2.503 mIU/mL Standard Deviation 2.2230	3.511 mIU/mL Standard Deviation 3.7050	5.064 mIU/mL Standard Deviation 3.9739	-0.341 mIU/mL Standard Deviation 1.4575
Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. Visit 6 (Week 16)	2.557 mIU/mL Standard Deviation 1.6964	3.704 mIU/mL Standard Deviation 3.6269	5.004 mIU/mL Standard Deviation 4.3397	-0.395 mIU/mL Standard Deviation 1.4793
Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. Visit 7 (Week 20)	2.553 mIU/mL Standard Deviation 2.2380	3.653 mIU/mL Standard Deviation 3.7381	4.884 mIU/mL Standard Deviation 3.9297	-0.193 mIU/mL Standard Deviation 1.3585
Mean (SD) Change From Baseline in Luteinizing Hormone (LH) to Week 24. Visit 8 (Week 24)	2.108 mIU/mL Standard Deviation 1.9892	3.560 mIU/mL Standard Deviation 3.6138	5.209 mIU/mL Standard Deviation 4.4894	-0.043 mIU/mL Standard Deviation 1.5575

SECONDARY outcome

Timeframe: Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

Population: ITT Population

FSH was measured at baseline, Visit 1 through 8 and follow-up. Baseline was defined as the last non-missing value collected before the first study treatment administration, including unscheduled assessments.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=67 Participants BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=65 Participants BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=66 Participants BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo n=69 Participants Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. Visit 2 (Day 8)	3.553 mIU/mL Standard Deviation 2.2022	4.575 mIU/mL Standard Deviation 2.0756	5.307 mIU/mL Standard Deviation 2.8315	-0.51 mIU/mL Standard Deviation 0.8273
Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. Visit 3 (Week 4)	4.158 mIU/mL Standard Deviation 2.1353	5.540 mIU/mL Standard Deviation 2.8344	6.551 mIU/mL Standard Deviation 4.2155	-0.111 mIU/mL Standard Deviation 1.0638
Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. Visit 4 (Week 8)	4.318 mIU/mL Standard Deviation 2.4147	5.878 mIU/mL Standard Deviation 2.9916	7.620 mIU/mL Standard Deviation 4.7883	0.047 mIU/mL Standard Deviation 1.2241
Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. Visit 5 (Week 12)	4.809 mIU/mL Standard Deviation 2.5582	5.768 mIU/mL Standard Deviation 3.2474	8.132 mIU/mL Standard Deviation 5.9526	-0.075 mIU/mL Standard Deviation 1.0723
Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. Visit 6 (Week 16)	5.188 mIU/mL Standard Deviation 2.6876	6.350 mIU/mL Standard Deviation 3.4261	8.045 mIU/mL Standard Deviation 6.1773	-0.165 mIU/mL Standard Deviation 1.1924
Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. Visit 7 (Week 20)	5.059 mIU/mL Standard Deviation 2.5714	6.073 mIU/mL Standard Deviation 3.5199	8.409 mIU/mL Standard Deviation 6.6502	-0.030 mIU/mL Standard Deviation 1.0932
Mean (SD) Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 24. Visit 8 (Week 24)	4.836 mIU/mL Standard Deviation 2.6901	6.183 mIU/mL Standard Deviation 3.4817	8.282 mIU/mL Standard Deviation 7.0523	0.038 mIU/mL Standard Deviation 1.2164

SECONDARY outcome

Timeframe: Week 12 (pre-dose and 1 hour post-dose), week 24 and week 24/End of treatment

Population: PK population

Plasma PK sampling for BGS649 was performed at Weeks 12 and 24. BGS649 PK plasma concentrations were summarised for the PK population by descriptive statistics.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=64 Participants BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=59 Participants BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=65 Participants BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. Visit 5 (Week 12), Pre-Dose	0.73 ng/mL Interval 0.64 to 0.83	2.55 ng/mL Interval 2.33 to 2.8	8.93 ng/mL Interval 8.29 to 9.62	—
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. Visit 5 (Week 12), 1 hour Post-Dose	1.43 ng/mL Interval 1.24 to 1.65	4.39 ng/mL Interval 3.89 to 4.97	14.91 ng/mL Interval 13.52 to 16.45	—
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. Visit 8 (Week 24)	0.85 ng/mL Interval 0.72 to 1.0	2.97 ng/mL Interval 2.2 to 4.0	10.04 ng/mL Interval 8.23 to 12.25	—
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Plasma PK Concentration Values to 24 Weeks. Visit 8 (Week 24)/End of Treatment	0.78 ng/mL Interval 0.64 to 0.97	2.76 ng/mL Interval 2.14 to 3.57	9.10 ng/mL Interval 7.61 to 10.89	—

SECONDARY outcome

Timeframe: Week 24 and week 24/End of treatment

Population: PK population

Semen PK sampling for BGS649 was performed at Visit 8 (End of Treatment). BGS649 PK semen concentrations were summarised for the PK population by descriptive statistics.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=64 Participants BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=59 Participants BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=65 Participants BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks. Visit 8 (Week 24)	0.51 ng/mL Interval 0.43 to 0.61	1.95 ng/mL Interval 1.6 to 2.38	5.81 ng/mL Interval 4.63 to 7.28	—
Descriptive Summary (Geometric Mean [95% CI]) of BGS649 Semen PK Concentration Values at 24 Weeks. Visit 8 (Week 24)/End of Treatment	0.49 ng/mL Interval 0.42 to 0.58	1.58 ng/mL Interval 1.19 to 2.08	5.28 ng/mL Interval 4.16 to 6.71	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

Population: Safety Population

PSA was measured alongside other clinical chemistry parameters at screening, baseline, Visits 1 through 8 and at follow-up.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=67 Participants BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=66 Participants BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=67 Participants BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo n=71 Participants Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. Visit 2 (Day 8)	0.045 ug/L Standard Deviation 0.1840	0.040 ug/L Standard Deviation 0.4830	0.011 ug/L Standard Deviation 0.4606	0.015 ug/L Standard Deviation 0.2179
Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. Visit 3 (Week 4)	0.141 ug/L Standard Deviation 0.1742	0.082 ug/L Standard Deviation 0.5198	0.092 ug/L Standard Deviation 0.4338	0.038 ug/L Standard Deviation 0.2700
Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. Visit 4 (Week 8)	0.166 ug/L Standard Deviation 0.2651	0.105 ug/L Standard Deviation 0.4747	0.132 ug/L Standard Deviation 0.3343	0.055 ug/L Standard Deviation 0.4500
Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. Visit 5 (Week 12)	0.190 ug/L Standard Deviation 0.3895	0.271 ug/L Standard Deviation 0.9626	0.178 ug/L Standard Deviation 0.5405	0.039 ug/L Standard Deviation 0.4382
Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. Visit 6 (Week 16)	0.147 ug/L Standard Deviation 0.2655	0.102 ug/L Standard Deviation 0.5500	0.160 ug/L Standard Deviation 0.4037	0.016 ug/L Standard Deviation 0.2631
Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. Visit 7 (Week 20)	0.158 ug/L Standard Deviation 0.2913	0.480 ug/L Standard Deviation 2.6029	0.116 ug/L Standard Deviation 0.4560	0.022 ug/L Standard Deviation 0.3942
Mean (SD) Change From Baseline in Prostate Specific Antigen (PSA) to Week 24. Visit 8 (Week 24)	0.218 ug/L Standard Deviation 0.4312	0.391 ug/L Standard Deviation 1.8627	0.085 ug/L Standard Deviation 0.2930	0.067 ug/L Standard Deviation 0.4787

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 8, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks

Population: Safety Population

Haematocrit was measured alongside other haematology parameters at screening, baseline, Visits 1 through 8 and at follow-up.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=67 Participants BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=66 Participants BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=67 Participants BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo n=71 Participants Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Mean (SD) Change From Baseline in Haematocrit to Week 24. Visit 6 (Week 16)	0.0142 Ratio Standard Deviation 0.02195	0.0233 Ratio Standard Deviation 0.02408	0.0229 Ratio Standard Deviation 0.03260	-0.0079 Ratio Standard Deviation 0.02533
Mean (SD) Change From Baseline in Haematocrit to Week 24. Visit 2 (Day 8)	-0.0003 Ratio Standard Deviation 0.02279	0.0014 Ratio Standard Deviation 0.01945	-0.0016 Ratio Standard Deviation 0.03487	-0.0029 Ratio Standard Deviation 0.02374
Mean (SD) Change From Baseline in Haematocrit to Week 24. Visit 3 (Week 4)	0.0036 Ratio Standard Deviation 0.01855	0.0024 Ratio Standard Deviation 0.02095	0.0067 Ratio Standard Deviation 0.02997	-0.0024 Ratio Standard Deviation 0.02539
Mean (SD) Change From Baseline in Haematocrit to Week 24. Visit 4 (Week 8)	0.0151 Ratio Standard Deviation 0.02153	0.0162 Ratio Standard Deviation 0.02709	0.0258 Ratio Standard Deviation 0.03233	-0.0041 Ratio Standard Deviation 0.02383
Mean (SD) Change From Baseline in Haematocrit to Week 24. Visit 5 (Week 12)	0.0153 Ratio Standard Deviation 0.02419	0.0175 Ratio Standard Deviation 0.02270	0.0256 Ratio Standard Deviation 0.02906	-0.0082 Ratio Standard Deviation 0.02882
Mean (SD) Change From Baseline in Haematocrit to Week 24. Visit 7 (Week 20)	0.0195 Ratio Standard Deviation 0.02545	0.0192 Ratio Standard Deviation 0.02672	0.0187 Ratio Standard Deviation 0.03222	-0.0063 Ratio Standard Deviation 0.03037
Mean (SD) Change From Baseline in Haematocrit to Week 24. Visit 8 (Week 24)	0.0171 Ratio Standard Deviation 0.02612	0.0159 Ratio Standard Deviation 0.02621	0.0216 Ratio Standard Deviation 0.02587	-0.0032 Ratio Standard Deviation 0.02884

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening to Week 24

Population: Safety Population

Summary of DEXA Scan T-score at Visit 8 (Week 24) in the hip, femoral neck, and lumber spine. DEXA T-score was calculated based on actual measured bone density value and compared to a standard reference range for healthy young adult men. A bone density scan compares bone density with the bone density expected for a young healthy adult or a healthy adult of the same age, gender and ethnicity. The difference is calculated as a standard deviation (SD) score. The measures between the bone density and the expected value of a young healthy adult is known as the T score. The World Health Organization (WHO) classifies T scores as follows: * above -1 SD is normal * between -1 and -2.5 SD is defined as mildly reduced bone mineral density (BMD) compared with peak bone mass (PBM) * at or below -2.5 SD is defined as osteoporosis

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=67 Participants BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=66 Participants BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=67 Participants BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo n=71 Participants Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. Lumber spine	-0.12 T-score Standard Deviation 0.279	-0.08 T-score Standard Deviation 0.381	-0.22 T-score Standard Deviation 0.351	0.07 T-score Standard Deviation 0.346
Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. Hip	0.01 T-score Standard Deviation 0.382	0.05 T-score Standard Deviation 0.315	-0.02 T-score Standard Deviation 0.323	0.01 T-score Standard Deviation 0.266
Mean (SD) Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan T-score by Location at Week 24. Femoral neck	-0.16 T-score Standard Deviation 0.337	0.02 T-score Standard Deviation 0.441	-0.11 T-score Standard Deviation 0.392	0.03 T-score Standard Deviation 0.212

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening to Week 24

Population: Safety Population

Summary of DEXA scan density at Visit 8 (Week 24) in the hip, femoral neck, and lumber spine. Bone density was evaluated with standard procedure for Hologic and General Electric Lunar scanners.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=67 Participants BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=66 Participants BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=67 Participants BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo n=71 Participants Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 Hip	-0.0026 g/cm^2 Standard Deviation 0.03990	-0.0020 g/cm^2 Standard Deviation 0.03828	-0.0072 g/cm^2 Standard Deviation 0.02724	0.0005 g/cm^2 Standard Deviation 0.03315
Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 Femoral neck	-0.0248 g/cm^2 Standard Deviation 0.04583	-0.0044 g/cm^2 Standard Deviation 0.06666	-0.0116 g/cm^2 Standard Deviation 0.05139	0.0028 g/cm^2 Standard Deviation 0.02747
Mean (SD) Change From Baseline in DEXA Scan Density by Location at Week 24 Lumber spine	-0.0167 g/cm^2 Standard Deviation 0.03174	-0.0177 g/cm^2 Standard Deviation 0.05018	-0.0255 g/cm^2 Standard Deviation 0.04044	0.0100 g/cm^2 Standard Deviation 0.04016

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening to Week 24

Population: ITT Population. Discrepancies in numbers from the progress flow are due to missing samples either at baseline or wk 24/EOT.

Descriptive statistics were presented for the following bone turnover marker parameters: type I collagen C-telopeptides, procollagen 1 N-terminal propeptide, osteocalcin, and bone specific alkaline phosphatase.

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=67 Participants BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=65 Participants BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=67 Participants BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo n=71 Participants Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24. Type I Collagen C-Telopeptides	0.054 ug/L Standard Deviation 0.1454	0.069 ug/L Standard Deviation 0.1618	0.047 ug/L Standard Deviation 0.1342	0.020 ug/L Standard Deviation 0.2087
Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24. Procollagen 1 N-Terminal Propeptide	5.2 ug/L Standard Deviation 8.31	5.0 ug/L Standard Deviation 11.93	4.3 ug/L Standard Deviation 11.68	1.8 ug/L Standard Deviation 11.61
Mean (SD) Change From Baseline in Bone Turnover Markers by Parameter at Week 24. Osteocalcin	0.72 ug/L Standard Deviation 2.891	0.35 ug/L Standard Deviation 3.801	0.36 ug/L Standard Deviation 3.604	0.30 ug/L Standard Deviation 3.267

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks

Population: ITT population on all available samples and including all wk 24 and end-of-treatment visit data.

Change from baseline in bone specific alkaline phosphatase at week 24 measured in U/L

Outcome measures

Outcome measures
Measure	BGS649 0.1 mg n=58 Participants BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=51 Participants BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=56 Participants BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo n=55 Participants Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Change From Baseline in Bone Specific Alkaline Phosphatase at Week 24.	0.15 U/L Standard Deviation 3.187	0.69 U/L Standard Deviation 4.556	0.03 U/L Standard Deviation 3.629	0.29 U/L Standard Deviation 3.197

Adverse Events

BGS649 0.1 mg

Serious events: 2 serious events

Other events: 37 other events

Deaths: 0 deaths

BGS649 0.3 mg

Serious events: 2 serious events

Other events: 39 other events

Deaths: 0 deaths

BGS649 1.0 mg

Serious events: 5 serious events

Other events: 47 other events

Deaths: 0 deaths

Placebo

Serious events: 5 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Jackie Parkin

Mereo BioPharma Group

Phone: +44 (0) 333 023 7300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	BGS649 0.1 mg n=67 participants at risk BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=66 participants at risk BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=67 participants at risk BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo n=71 participants at risk Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Infections and infestations Postoperative wound infection	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Arthritis infective	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Diverticulitis	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Osteomyelitis	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 4 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Pneumonia	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Pyelonephritis	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Sepsis	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
General disorders Chest pain	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
General disorders Multiple organ dysfunction syndrome	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Cardiac disorders Cardiac arrest	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Cardiac disorders Pericardial effusion	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/66 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Renal and urinary disorders Acute kidney injury	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Renal and urinary disorders Ureterolithiasis	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Blood and lymphatic system disorders Anaemia	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Gastrointestinal disorders Intestinal perforation	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Injury, poisoning and procedural complications Skull fracture	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/66 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Nervous system disorders Syncope	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/66 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Vascular disorders Hypertension	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.

Other adverse events
Measure	BGS649 0.1 mg n=67 participants at risk BGS649 0.1 mg weekly (1 BGS649 0.1 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 0.3 mg n=66 participants at risk BGS649 0.3 mg weekly (3 BGS649 0.1 mg capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	BGS649 1.0 mg n=67 participants at risk BGS649 1.0 mg weekly (1 BGS649 1.0 mg capsule and 2 indistinguishable placebo capsules) BGS649: Capsules will be taken weekly for a maximum of 24 weeks	Placebo n=71 participants at risk Placebo weekly (3 indistinguishable placebo capsules) Placebo: Capsules will be taken weekly for a maximum of 24 weeks
Infections and infestations Upper respiratory tract infection	4.5% 3/67 • Number of events 4 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	4.5% 3/66 • Number of events 4 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	3.0% 2/67 • Number of events 2 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	7.0% 5/71 • Number of events 5 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Nasopharyngitis	3.0% 2/67 • Number of events 2 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	3.0% 2/66 • Number of events 2 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Sinusitis	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/66 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	2.8% 2/71 • Number of events 2 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Influenza	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/66 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Urinary tract infection	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	3.0% 2/66 • Number of events 2 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 2 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Gastroenteritis	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/66 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Osteomyelitis	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Pneumonia	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Sepsis	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Tooth abscess	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Tooth infection	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/66 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Bacterial prostatitis	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Bronchitis	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Conjunctivitis	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Ear infection	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/66 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Folliculitis	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Furuncle	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Gastritis viral	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Gastroenteritis norovirus	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Lower respiratory tract infection	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Oral herpes	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Otitis externa	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Otitis media	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Otitis media acute	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Rash pustular	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 2 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Respiratory tract infection	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Tinea pedis	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/66 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Investigations Haematocrit increased	1.5% 1/67 • Number of events 2 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	6.1% 4/66 • Number of events 5 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	7.5% 5/67 • Number of events 6 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Investigations Prostatic specific antigen increased	3.0% 2/67 • Number of events 2 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/66 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	6.0% 4/67 • Number of events 4 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	2.8% 2/71 • Number of events 2 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Investigations Blood triglycerides increased	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	3.0% 2/66 • Number of events 2 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	2.8% 2/71 • Number of events 2 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Investigations Weight increased	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/66 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	3.0% 2/67 • Number of events 2 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Investigations Blood creatinine increased	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Investigations Blood pressure increased	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/66 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	3.0% 2/67 • Number of events 2 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Investigations Aspartate aminotransferase increased	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/66 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 2 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Investigations Hepatic enzyme increased	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Investigations Alanine aminotransferase increased	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Investigations Blood bilirubin increased	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Investigations Blood glucose increased	1.5% 1/67 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/71 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.
Investigations Blood insulin increased	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/66 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	0.00% 0/67 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.	1.4% 1/71 • Number of events 1 • After randomisation and up to 90 days after the last administration of study drug. The following variables were recorded for each AE: verbatim/AE description and date for AE start and stop, severity, seriousness, causality rating, whether or not the AE caused the subject to discontinue, and the outcome. If the severity of the AE changed, a new AE had to be recorded. All ongoing AEs/SAEs were followed up until resolution or stabilisation or the last visit if in the Investigator's opinion, the AE was unlikely to resolve due to the subject's underlying disease.