Trial Outcomes & Findings for Dose-finding Study With ACT-132577 (Aprocitentan) in Participants With Essential Hypertension (NCT NCT02603809)

NCT ID: NCT02603809

Last Updated: 2022-11-23

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1659 participants

Primary outcome timeframe

Baseline (Day 1) and end of double-blind treatment (Day 56)

Results posted on

2022-11-23

Participant Flow

The study was conducted at 99 sites in 3 countries. Of the 1659 participants that signed the informed consent 996 entered the run-in period (i.e. 663 participants were screening failures: 651 failed to meet the eligibility criteria to enter the run-in period, 6 withdrew and 6 did not enter the run-in period for other reasons).

Of the 996 participants enrolled into the run-in period, a total 992 participants received at least one dose of the single-blind placebo. Of these 992 participants 502 were considered run-in failures (390 failing to meet randomization criteria, 57 withdrew consent and 55 left for other reasons) and 490 participants were randomized into the study.

Participant milestones

Participant milestones
Measure	Placebo After a 4 to 6-week single-blind placebo run-in period, participants received placebo orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Aprocitentan 5 mg After a 4 to 6-week single-blind placebo run-in period, participants received 5 mg aprocitentan orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Aprocitentan 10 mg After a 4 to 6-week single-blind placebo run-in period, participants received aprocitentan 10 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Aprocitentan 25 mg After a 4 to 6-week single-blind placebo run-in period, participants received aprocitentan 25 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Aprocitentan 50 mg After a 4 to 6-week single-blind placebo run-in period, participants received aprocitentan 50 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Lisinopril 20 mg After a 4 to 6-week single-blind placebo run-in period, participants received lisinopril 20 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Overall Study STARTED	82	82	82	82	81	81
Overall Study Per-protocol Set	67	68	71	67	68	69
Overall Study Modified Per-Protocol Set	66	68	71	67	68	69
Overall Study Completed Study	75	79	79	76	78	75
Overall Study COMPLETED	70	74	75	70	70	71
Overall Study NOT COMPLETED	12	8	7	12	11	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo After a 4 to 6-week single-blind placebo run-in period, participants received placebo orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Aprocitentan 5 mg After a 4 to 6-week single-blind placebo run-in period, participants received 5 mg aprocitentan orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Aprocitentan 10 mg After a 4 to 6-week single-blind placebo run-in period, participants received aprocitentan 10 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Aprocitentan 25 mg After a 4 to 6-week single-blind placebo run-in period, participants received aprocitentan 25 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Aprocitentan 50 mg After a 4 to 6-week single-blind placebo run-in period, participants received aprocitentan 50 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Lisinopril 20 mg After a 4 to 6-week single-blind placebo run-in period, participants received lisinopril 20 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Overall Study Withdrawal by Subject	4	1	2	3	3	4
Overall Study Lost to Follow-up	2	3	1	4	2	2
Overall Study Pre-specified discontinuation criteria	3	3	2	2	3	1
Overall Study Physician Decision	0	0	0	1	2	1
Overall Study Adverse Event	3	0	2	2	1	1
Overall Study Lack of Efficacy	0	1	0	0	0	1

Baseline Characteristics

Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=82 Participants Participants randomized to placebo treatment for 8 weeks.	Aprocitentan 5 mg n=82 Participants Participants randomized to 5 mg aprocitentan treatment for 8 weeks.	Aprocitentan 10 mg n=82 Participants Participants randomized to 10 mg aprocitentan treatment for 8 weeks.	Aprocitentan 25 mg n=82 Participants Participants randomized to 25 mg aprocitentan treatment for 8 weeks.	Aprocitentan 50 mg n=81 Participants Participants randomized to 50 mg aprocitentan treatment for 8 weeks.	Lisinopril 20 mg n=81 Participants Participants randomized to 20 mg lisinopril treatment for 8 weeks.	Total n=490 Participants Total of all reporting groups
Age, Continuous Full Analysis Set	53.5 years STANDARD_DEVIATION 9.1 • n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	54.1 years STANDARD_DEVIATION 8.5 • n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	55.3 years STANDARD_DEVIATION 9.8 • n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	55.1 years STANDARD_DEVIATION 10.0 • n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	54.2 years STANDARD_DEVIATION 9.3 • n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	56.0 years STANDARD_DEVIATION 9.0 • n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	54.7 years STANDARD_DEVIATION 9.3 • n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Age, Continuous Per Protocol Set	53.9 years STANDARD_DEVIATION 9.1 • n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	55.0 years STANDARD_DEVIATION 8.5 • n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	55.8 years STANDARD_DEVIATION 9.5 • n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	55.7 years STANDARD_DEVIATION 9.8 • n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	54.0 years STANDARD_DEVIATION 9.4 • n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	56.1 years STANDARD_DEVIATION 9.4 • n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	55.1 years STANDARD_DEVIATION 9.3 • n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Age, Continuous modified Per Protocol Set	54.0 years STANDARD_DEVIATION 9.1 • n=66 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	55.0 years STANDARD_DEVIATION 8.5 • n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	55.8 years STANDARD_DEVIATION 9.5 • n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	55.7 years STANDARD_DEVIATION 9.8 • n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	54.0 years STANDARD_DEVIATION 9.4 • n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	56.1 years STANDARD_DEVIATION 9.4 • n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	55.1 years STANDARD_DEVIATION 9.3 • n=409 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Sex: Female, Male Full Analysis Set · Female	27 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	34 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	31 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	37 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	28 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	36 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	193 Participants n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Sex: Female, Male Full Analysis Set · Male	55 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	48 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	51 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	45 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	53 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	45 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	297 Participants n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Sex: Female, Male Per Protocol Set · Female	22 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	27 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	26 Participants n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	30 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	24 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	31 Participants n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	160 Participants n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Sex: Female, Male Per Protocol Set · Male	45 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	41 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	45 Participants n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	37 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	44 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	38 Participants n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	250 Participants n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Sex: Female, Male modified Per Protocol Set · Female	22 Participants n=66 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	27 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	26 Participants n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	30 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	24 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	31 Participants n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	160 Participants n=409 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Sex: Female, Male modified Per Protocol Set · Male	44 Participants n=66 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	41 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	45 Participants n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	37 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	44 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	38 Participants n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	249 Participants n=409 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Ethnicity (NIH/OMB) Full Analysis Set · Hispanic or Latino	23 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	26 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	31 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	27 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	28 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	26 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	161 Participants n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Ethnicity (NIH/OMB) Full Analysis Set · Not Hispanic or Latino	59 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	56 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	51 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	55 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	53 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	55 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	329 Participants n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Ethnicity (NIH/OMB) Full Analysis Set · Unknown or Not Reported	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Ethnicity (NIH/OMB) Per Protocol Set · Hispanic or Latino	19 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	22 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	28 Participants n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	24 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	25 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	23 Participants n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	141 Participants n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Ethnicity (NIH/OMB) Per Protocol Set · Not Hispanic or Latino	48 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	46 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	43 Participants n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	43 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	43 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	46 Participants n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	269 Participants n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Ethnicity (NIH/OMB) Per Protocol Set · Unknown or Not Reported	0 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Race (NIH/OMB) Full Analysis Set · American Indian or Alaska Native	1 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	2 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	1 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	4 Participants n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Race (NIH/OMB) Full Analysis Set · Asian	2 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	1 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	2 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	5 Participants n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Race (NIH/OMB) Full Analysis Set · Native Hawaiian or Other Pacific Islander	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	1 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	1 Participants n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Race (NIH/OMB) Full Analysis Set · Black or African American	31 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	28 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	26 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	35 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	26 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	32 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	178 Participants n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Race (NIH/OMB) Full Analysis Set · White	48 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	54 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	53 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	46 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	55 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	46 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	302 Participants n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Race (NIH/OMB) Full Analysis Set · More than one race	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Race (NIH/OMB) Full Analysis Set · Unknown or Not Reported	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Race (NIH/OMB) Per Protocol Set · American Indian or Alaska Native	0 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	2 Participants n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	1 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	3 Participants n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Race (NIH/OMB) Per Protocol Set · Asian	1 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	1 Participants n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	1 Participants n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	3 Participants n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Race (NIH/OMB) Per Protocol Set · Native Hawaiian or Other Pacific Islander	0 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	1 Participants n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	1 Participants n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Race (NIH/OMB) Per Protocol Set · Black or African American	26 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	22 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	19 Participants n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	26 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	21 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	26 Participants n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	140 Participants n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Race (NIH/OMB) Per Protocol Set · White	40 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	46 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	49 Participants n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	40 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	47 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	41 Participants n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	263 Participants n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Race (NIH/OMB) Per Protocol Set · More than one race	0 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Race (NIH/OMB) Per Protocol Set · Unknown or Not Reported	0 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	0 Participants n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Region of Enrollment Canada	3 participants n=82 Participants	1 participants n=82 Participants	6 participants n=82 Participants	4 participants n=82 Participants	2 participants n=81 Participants	5 participants n=81 Participants	21 participants n=490 Participants
Region of Enrollment United States	75 participants n=82 Participants	75 participants n=82 Participants	74 participants n=82 Participants	73 participants n=82 Participants	75 participants n=81 Participants	71 participants n=81 Participants	443 participants n=490 Participants
Region of Enrollment Israel	4 participants n=82 Participants	6 participants n=82 Participants	2 participants n=82 Participants	5 participants n=82 Participants	4 participants n=81 Participants	5 participants n=81 Participants	26 participants n=490 Participants
Weight Full Analysis Set	92.0 kilograms STANDARD_DEVIATION 18.9 • n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	88.6 kilograms STANDARD_DEVIATION 16.9 • n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	90.1 kilograms STANDARD_DEVIATION 18.3 • n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	91.1 kilograms STANDARD_DEVIATION 16.9 • n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	87.6 kilograms STANDARD_DEVIATION 15.8 • n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	87.0 kilograms STANDARD_DEVIATION 17.2 • n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	89.4 kilograms STANDARD_DEVIATION 17.37 • n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Weight Per Protocol Set	91.0 kilograms STANDARD_DEVIATION 19.2 • n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	88.3 kilograms STANDARD_DEVIATION 17.6 • n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	89.3 kilograms STANDARD_DEVIATION 19.0 • n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	91.7 kilograms STANDARD_DEVIATION 18.1 • n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	87.1 kilograms STANDARD_DEVIATION 15.8 • n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	86.5 kilograms STANDARD_DEVIATION 16.0 • n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	89.0 kilograms STANDARD_DEVIATION 17.7 • n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Weight modified Per Protocol Set	90.6 kilograms STANDARD_DEVIATION 19.0 • n=66 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	88.3 kilograms STANDARD_DEVIATION 17.6 • n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	89.3 kilograms STANDARD_DEVIATION 19.0 • n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	91.7 kilograms STANDARD_DEVIATION 18.1 • n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	87.1 kilograms STANDARD_DEVIATION 15.8 • n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	86.5 kilograms STANDARD_DEVIATION 16.0 • n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	89.0 kilograms STANDARD_DEVIATION 17.7 • n=409 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Body Mass Index Full Analysis Set	30.6 kilograms per square meter STANDARD_DEVIATION 5.07 • n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	30.1 kilograms per square meter STANDARD_DEVIATION 4.56 • n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	30.8 kilograms per square meter STANDARD_DEVIATION 4.52 • n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	31.0 kilograms per square meter STANDARD_DEVIATION 4.16 • n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	30.2 kilograms per square meter STANDARD_DEVIATION 4.55 • n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	30.4 kilograms per square meter STANDARD_DEVIATION 4.59 • n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	30.5 kilograms per square meter STANDARD_DEVIATION 4.57 • n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Body Mass Index Per Protocol Set	30.1 kilograms per square meter STANDARD_DEVIATION 5.1 • n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	29.8 kilograms per square meter STANDARD_DEVIATION 4.5 • n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	30.4 kilograms per square meter STANDARD_DEVIATION 4.6 • n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	31.0 kilograms per square meter STANDARD_DEVIATION 4.3 • n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	30.3 kilograms per square meter STANDARD_DEVIATION 4.7 • n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	30.4 kilograms per square meter STANDARD_DEVIATION 4.6 • n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	30.3 kilograms per square meter STANDARD_DEVIATION 4.6 • n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Body Mass Index modified Per Protocol Set	30.1 kilograms per square meter STANDARD_DEVIATION 5.1 • n=66 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	29.8 kilograms per square meter STANDARD_DEVIATION 4.5 • n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	30.4 kilograms per square meter STANDARD_DEVIATION 4.6 • n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	31.0 kilograms per square meter STANDARD_DEVIATION 4.3 • n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	30.3 kilograms per square meter STANDARD_DEVIATION 4.7 • n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	30.4 kilograms per square meter STANDARD_DEVIATION 4.6 • n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	30.3 kilograms per square meter STANDARD_DEVIATION 4.6 • n=409 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Duration of essential hypertension at screening Full Analysis Set	9.13 years STANDARD_DEVIATION 8.72 • n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	8.12 years STANDARD_DEVIATION 8.25 • n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	10.48 years STANDARD_DEVIATION 10.18 • n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	9.56 years STANDARD_DEVIATION 8.97 • n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	10.60 years STANDARD_DEVIATION 9.95 • n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	11.79 years STANDARD_DEVIATION 10.47 • n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	9.94 years STANDARD_DEVIATION 9.48 • n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Duration of essential hypertension at screening Per Protocol Set	9.24 years STANDARD_DEVIATION 8.93 • n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	8.38 years STANDARD_DEVIATION 8.62 • n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	10.6 years STANDARD_DEVIATION 10.51 • n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	9.19 years STANDARD_DEVIATION 8.61 • n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	10.35 years STANDARD_DEVIATION 10.07 • n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	12.53 years STANDARD_DEVIATION 10.88 • n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.	10.06 years STANDARD_DEVIATION 9.7 • n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation.
Antihypertensive treatment at screening Full Analysis Set	57 participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	56 participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	45 participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	49 participants n=82 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	54 participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	56 participants n=81 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	317 participants n=490 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Antihypertensive treatment at screening Per Protocol Set	46 participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	48 participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	38 participants n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	39 participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	45 participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	48 participants n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	264 participants n=410 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).
Antihypertensive treatment at screening modified Per Protocol Set	45 participants n=66 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	48 participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	38 participants n=71 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	39 participants n=67 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	45 participants n=68 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	48 participants n=69 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).	263 participants n=409 Participants • Per Protocol Set (PPS, N=410) 8 weeks in the double-blind period, and no major protocol deviation. In the placebo group, one participant had out of analysis window blood pressure measurement. This participant was part of the PPS but not part of the modified Per Protocol Set (N=409).

PRIMARY outcome

Timeframe: Baseline (Day 1) and end of double-blind treatment (Day 56)

Population: Modified Per-protocol set (mPPS). All participants who had a mean trough sitting diastolic blood pressure (SiDBP) at Week-8 of the double-blind treatment period and that did not have any major protocol deviation were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks.	Aprocitentan 5 mg n=68 Participants One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Aprocitentan 10 mg n=71 Participants Two capsules of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks.	Aprocitentan 25 mg n=67 Participants One capsule of 25 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Aprocitentan 50 mg n=68 Participants One capsule of 50 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Lisinopril 20 mg n=69 Participants One capsule of 20 mg lisinopril, orally, once daily in the morning for 8 weeks, along with placebo capsule matching aprocitentan.
Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough Absolute Change from Baseline to Week 8	-4.9 mmHg Standard Deviation 11.1	-6.3 mmHg Standard Deviation 8.9	-9.9 mmHg Standard Deviation 8.7	-12.0 mmHg Standard Deviation 8.2	-10.0 mmHg Standard Deviation 7.9	-8.4 mmHg Standard Deviation 9.6
Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough Baseline	97.5 mmHg Standard Deviation 5.4	97.8 mmHg Standard Deviation 5.5	97.7 mmHg Standard Deviation 4.3	97.8 mmHg Standard Deviation 4.8	98.2 mmHg Standard Deviation 5.3	96.8 mmHg Standard Deviation 4.6

SECONDARY outcome

Timeframe: Baseline (Day 1) and end of double-blind treatment (Day 56)

Population: Modified Per-protocol set (mPPS). All participants who had a mean trough sitting systolic blood pressure (SiSBP) at Week 8 of the double-blind treatment period and that did not have any major protocol deviation were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks.	Aprocitentan 5 mg n=68 Participants One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Aprocitentan 10 mg n=71 Participants Two capsules of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks.	Aprocitentan 25 mg n=67 Participants One capsule of 25 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Aprocitentan 50 mg n=68 Participants One capsule of 50 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Lisinopril 20 mg n=69 Participants One capsule of 20 mg lisinopril, orally, once daily in the morning for 8 weeks, along with placebo capsule matching aprocitentan.
Change From Baseline to End of Double-blind Treatment in Sitting Systolic Blood Pressure at Trough Baseline	149.2 mmHg Standard Deviation 13.1	149.4 mmHg Standard Deviation 13.9	149.8 mmHg Standard Deviation 12.7	151.2 mmHg Standard Deviation 13.7	148.6 mmHg Standard Deviation 12.8	149.8 mmHg Standard Deviation 14.2
Change From Baseline to End of Double-blind Treatment in Sitting Systolic Blood Pressure at Trough Absolute Change from Baseline to Week 8	-7.7 mmHg Standard Deviation 18.8	-10.3 mmHg Standard Deviation 15.3	-15.0 mmHg Standard Deviation 14.5	-18.5 mmHg Standard Deviation 15.0	-15.1 mmHg Standard Deviation 11.8	-12.8 mmHg Standard Deviation 16.0

SECONDARY outcome

Timeframe: End of double-blind treatment (Day 56)

Population: Modified Per Protocol Set (mPPS). All participants who had diastolic and systolic blood pressure measurements at Week 8 of the double-blind treatment period and that did not have any major protocol deviation were analyzed.

Participants had their blood pressure measured at the study site using the BpTRU® device. The BpTRU® is an automatic unattended office blood pressure measurement device. Six measurements, at rest, per participant per visit were performed. The mean of the last 5 measurements was used for the analysis. The Canadian Hypertension Education Program (CHEP) issued guidelines proposing cut-offs of 85 mmHg for diastolic blood pressure and 135 mmHg for systolic blood pressure specifically focusing on measurement by automated office blood pressure measurement. The number of participants at the end of the 8-week treatment period that had values below the protocol and CHEP cut-off values are reported. The initial protocol control rates at Week 8 (Day 56) on trough SiDBP are also reported and were defined as a SiDBP of less than 90 mmHg and a SiSBP of less than 140 mmHg.

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks.	Aprocitentan 5 mg n=68 Participants One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Aprocitentan 10 mg n=71 Participants Two capsules of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks.	Aprocitentan 25 mg n=67 Participants One capsule of 25 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Aprocitentan 50 mg n=68 Participants One capsule of 50 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Lisinopril 20 mg n=69 Participants One capsule of 20 mg lisinopril, orally, once daily in the morning for 8 weeks, along with placebo capsule matching aprocitentan.
Control Rates at the End of the Double-blind Treatment Period Based on Trough Sitting Diastolic and Systolic Blood Pressure SiDBP less than 90 mmHg	22 Participants	30 Participants	37 Participants	43 Participants	39 Participants	38 Participants
Control Rates at the End of the Double-blind Treatment Period Based on Trough Sitting Diastolic and Systolic Blood Pressure SiDBP less than 85 mmHg (CHEP)	17 Participants	15 Participants	29 Participants	29 Participants	21 Participants	23 Participants
Control Rates at the End of the Double-blind Treatment Period Based on Trough Sitting Diastolic and Systolic Blood Pressure SiSBP less than 140 mmHg	34 Participants	37 Participants	43 Participants	44 Participants	47 Participants	39 Participants
Control Rates at the End of the Double-blind Treatment Period Based on Trough Sitting Diastolic and Systolic Blood Pressure SiSBP less than 135 mmHg (CHEP)	24 Participants	27 Participants	32 Participants	38 Participants	36 Participants	31 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and end of double-blind treatment (Day 56)

Population: Modified Per Protocol Set (mPPS).

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks.	Aprocitentan 5 mg n=68 Participants One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Aprocitentan 10 mg n=71 Participants Two capsules of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks.	Aprocitentan 25 mg n=67 Participants One capsule of 25 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Aprocitentan 50 mg n=68 Participants One capsule of 50 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Lisinopril 20 mg n=69 Participants One capsule of 20 mg lisinopril, orally, once daily in the morning for 8 weeks, along with placebo capsule matching aprocitentan.
Response Rates at End of Double-blind Treatment Period Based on Trough Sitting Diastolic Blood Pressure	21 Participants	21 Participants	34 Participants	40 Participants	38 Participants	31 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and end of double-blind treatment (Day 56)

Population: Modified Per Protocol Set (mPPS).

Outcome measures

Outcome measures
Measure	Placebo n=66 Participants One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks.	Aprocitentan 5 mg n=68 Participants One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Aprocitentan 10 mg n=71 Participants Two capsules of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks.	Aprocitentan 25 mg n=67 Participants One capsule of 25 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Aprocitentan 50 mg n=68 Participants One capsule of 50 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Lisinopril 20 mg n=69 Participants One capsule of 20 mg lisinopril, orally, once daily in the morning for 8 weeks, along with placebo capsule matching aprocitentan.
Response Rates at End of Double-blind Treatment Period Based on Trough Sitting Systolic Blood Pressure	16 Participants	16 Participants	22 Participants	28 Participants	22 Participants	20 Participants

SECONDARY outcome

Timeframe: Baseline (Day -1 to Day 1) and end of double-blind treatment (Day 55 and Day 56)

Population: All participants in a treatment group with a full set of ABPM (Ambulatory Blood Pressure Monitoring) values over the 24-hour period at baseline and at Week 8.

Diastolic and systolic ambulatory blood pressure monitoring was performed over a 24-hour period with the ABPM device (Mobil-o-Graph) set to record diastolic and systolic blood pressure at a pre-defined time. Over a 24-hour period 3 measurements per hour during the day and 2 per hour during the night were made. The blood pressure measurements were derived from the area under the diastolic and systolic blood pressure curves and divided by the time span and averaged. For ambulatory blood pressure monitoring the baseline was the period from the time of last run-in placebo intake up to the time of the first double-blind treatment intake.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks.	Aprocitentan 5 mg n=36 Participants One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Aprocitentan 10 mg n=36 Participants Two capsules of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks.	Aprocitentan 25 mg n=30 Participants One capsule of 25 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Aprocitentan 50 mg n=33 Participants One capsule of 50 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Lisinopril 20 mg n=30 Participants One capsule of 20 mg lisinopril, orally, once daily in the morning for 8 weeks, along with placebo capsule matching aprocitentan.
Change From Baseline to End of Double-blind Treatment in 24-hour Diastolic and Systolic Ambulatory Blood Pressure Monitoring (ABPM) Absolute change in 24-hour mean SBP at Week 8	-3.54 mmHg Standard Error 7.46	-3.16 mmHg Standard Error 10.54	-7.72 mmHg Standard Error 11.37	-9.23 mmHg Standard Error 9.92	-6.07 mmHg Standard Error 8.93	-7.23 mmHg Standard Error 14.33
Change From Baseline to End of Double-blind Treatment in 24-hour Diastolic and Systolic Ambulatory Blood Pressure Monitoring (ABPM) Baseline 24-hour mean DBP	90.46 mmHg Standard Error 10.66	90.60 mmHg Standard Error 10.19	92.60 mmHg Standard Error 10.92	89.28 mmHg Standard Error 9.53	91.53 mmHg Standard Error 10.54	91.18 mmHg Standard Error 9.48
Change From Baseline to End of Double-blind Treatment in 24-hour Diastolic and Systolic Ambulatory Blood Pressure Monitoring (ABPM) Absolute change in 24-hour mean DBP at Week 8	-2.49 mmHg Standard Error 5.52	-3.76 mmHg Standard Error 6.36	-6.55 mmHg Standard Error 7.04	-8.86 mmHg Standard Error 7.35	-5.98 mmHg Standard Error 6.63	-5.72 mmHg Standard Error 9.12
Change From Baseline to End of Double-blind Treatment in 24-hour Diastolic and Systolic Ambulatory Blood Pressure Monitoring (ABPM) Baseline 24-hour mean SBP	140.28 mmHg Standard Error 14.2	139.90 mmHg Standard Error 15.87	144.30 mmHg Standard Error 15.68	140.83 mmHg Standard Error 11.23	141.28 mmHg Standard Error 14.73	143.35 mmHg Standard Error 17.53

SECONDARY outcome

Timeframe: Baseline (Day -1 to Day 1) and end of double-blind treatment (Day 55 and Day 56)

Population: All participants in a treatment group with a full set of ABPM (Ambulatory Blood Pressure Monitoring) values over the 24-hour period at baseline and at Week 8.

Ratio of group mean at trough to group mean at peak was calculated from the diastolic ambulatory blood pressure monitoring performed over a 24-hour period with the ABPM device. The trough (the smallest blood pressure reduction) and the peak (the highest blood pressure reduction) ratio show the extent of blood pressure lowering throughout the 24-hour dosing interval in the group. The group mean trough (at 20-24 hours) to group mean (at 2-6 hours) peak of diastolic blood pressure were examined to evaluate the extent to which once-daily dosing criteria were met (trough-to-peak values greater than 0.5). The ratio is positive if there was a decrease in diastolic blood pressure at both the trough and peak times at the end of treatment (Day 55 to Day 56) when compared to baseline (Day -1 to Day 1). For ambulatory blood pressure monitoring the baseline was the period from the time of last run-in placebo intake up to the time of the first double-blind treatment intake.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks.	Aprocitentan 5 mg n=37 Participants One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Aprocitentan 10 mg n=36 Participants Two capsules of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks.	Aprocitentan 25 mg n=30 Participants One capsule of 25 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Aprocitentan 50 mg n=33 Participants One capsule of 50 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Lisinopril 20 mg n=30 Participants One capsule of 20 mg lisinopril, orally, once daily in the morning for 8 weeks, along with placebo capsule matching aprocitentan.
Ratio of Group Mean at Trough to Group Mean at Peak for Diastolic Blood Pressure Based on Ambulatory Blood Pressure Monitoring (ABPM)	-48.03 Ratio of mean at trough to mean at peak	2.59 Ratio of mean at trough to mean at peak	0.90 Ratio of mean at trough to mean at peak	1.49 Ratio of mean at trough to mean at peak	1.25 Ratio of mean at trough to mean at peak	0.65 Ratio of mean at trough to mean at peak

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day -1 to Day 1) and end of double-blind treatment (Day 55 and Day 56)

Population: The Full Analysis Set (FAS) includes all participants randomized who had a baseline mean trough SiDBP. Participants were evaluated according to the study treatment they have been assigned to. Missing data was analyzed by LOCF (Last Observation Carried Forward).

Outcome measures

Outcome measures
Measure	Placebo n=81 Participants One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks.	Aprocitentan 5 mg n=79 Participants One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Aprocitentan 10 mg n=80 Participants Two capsules of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks.	Aprocitentan 25 mg n=77 Participants One capsule of 25 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Aprocitentan 50 mg n=77 Participants One capsule of 50 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.	Lisinopril 20 mg n=79 Participants One capsule of 20 mg lisinopril, orally, once daily in the morning for 8 weeks, along with placebo capsule matching aprocitentan.
Supportive Analysis of Primary Endpoint: Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough Baseline	98.0 mmHg Standard Deviation 5.5	97.5 mmHg Standard Deviation 5.3	97.7 mmHg Standard Deviation 4.2	98.2 mmHg Standard Deviation 5.0	98.4 mmHg Standard Deviation 5.3	96.9 mmHg Standard Deviation 4.4
Supportive Analysis of Primary Endpoint: Change From Baseline to End of Double-blind Treatment in Sitting Diastolic Blood Pressure at Trough Absolute Change from Baseline to Week 8	-4.2 mmHg Standard Deviation 11.1	-5.8 mmHg Standard Deviation 8.9	-9.9 mmHg Standard Deviation 8.4	-11.7 mmHg Standard Deviation 7.8	-9.9 mmHg Standard Deviation 7.8	-8.2 mmHg Standard Deviation 9.7

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Aprocitentan 5 mg

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Aprocitentan 10 mg

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Aprocitentan 25 mg

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Aprocitentan 50 mg

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Lisinopril 20 mg

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=82 participants at risk Participants received placebo orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Aprocitentan 5 mg n=82 participants at risk Participants received aprocitentan 5 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Aprocitentan 10 mg n=82 participants at risk Participants received aprocitentan 10 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Aprocitentan 25 mg n=82 participants at risk Participants received aprocitentan 25 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Aprocitentan 50 mg n=81 participants at risk Participants received aprocitentan 50 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Lisinopril 20 mg n=81 participants at risk Participants received lisinopril 20 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Cardiac disorders Bundle branch block left	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Injury, poisoning and procedural complications Fall	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.

Other adverse events

Other adverse events
Measure	Placebo n=82 participants at risk Participants received placebo orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Aprocitentan 5 mg n=82 participants at risk Participants received aprocitentan 5 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Aprocitentan 10 mg n=82 participants at risk Participants received aprocitentan 10 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Aprocitentan 25 mg n=82 participants at risk Participants received aprocitentan 25 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Aprocitentan 50 mg n=81 participants at risk Participants received aprocitentan 50 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.	Lisinopril 20 mg n=81 participants at risk Participants received lisinopril 20 mg orally once daily in the morning for 8 weeks during the double-blind treatment period, followed by a 2-week single-blind placebo washout period, followed by a further two-week follow-up period.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Gastrointestinal disorders Abdominal pain	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Blood and lymphatic system disorders Anaemia	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	2.4% 2/82 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Blood and lymphatic system disorders Leukopenia	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Blood and lymphatic system disorders Neutropenia	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Cardiac disorders Atrioventricular block first degree	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Cardiac disorders Palpitations	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Cardiac disorders Supraventricular tachycardia	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Cardiac disorders Tachycardia	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Ear and labyrinth disorders Deafness	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Ear and labyrinth disorders Deafness unilateral	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Ear and labyrinth disorders Ear pain	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Ear and labyrinth disorders Hypoacusis	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Ear and labyrinth disorders Motion sickness	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Ear and labyrinth disorders Tinnitus	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Ear and labyrinth disorders Vertigo	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Endocrine disorders Hyperthyroidism	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Eye disorders Eye haemorrhage	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Eye disorders Eye pain	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Eye disorders Lens disorder	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Eye disorders Vision blurred	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Eye disorders Vitreous degeneration	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Gastrointestinal disorders Constipation	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	3.7% 3/82 • Number of events 3 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Gastrointestinal disorders Diarrhoea	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Gastrointestinal disorders Dry mouth	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Gastrointestinal disorders Dyspepsia	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Gastrointestinal disorders Gastritis	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Gastrointestinal disorders Nausea	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Gastrointestinal disorders Oral pain	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Gastrointestinal disorders Toothache	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Gastrointestinal disorders Vomiting	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
General disorders Asthenia	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
General disorders Face oedema	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
General disorders Inflammation	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
General disorders Non-cardiac chest pain	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
General disorders Oedema peripheral	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	2.4% 2/82 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	2.5% 2/81 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
General disorders Tenderness	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Immune system disorders Hypersensitivity	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Abscess	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Bronchitis	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Gastroenteritis	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Influenza	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Laryngitis	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Localised infection	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Nasopharyngitis	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	2.4% 2/82 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	2.4% 2/82 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	4.9% 4/81 • Number of events 4 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Parotitis	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Pneumonia viral	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Rhinitis	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Sinusitis	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Tooth abscess	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Tooth infection	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Upper respiratory tract infection	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	4.9% 4/82 • Number of events 4 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	2.5% 2/81 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Urinary tract infection	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Viral infection	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Injury, poisoning and procedural complications Laceration	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Injury, poisoning and procedural complications Periorbital haemorrhage	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Injury, poisoning and procedural complications Skin abrasion	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Injury, poisoning and procedural complications Sunburn	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Injury, poisoning and procedural complications Wound	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Alanine aminotransferase increased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Aspartate aminotransferase increased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Blood creatinine increased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Blood glucose abnormal	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Blood glucose decreased	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Blood glucose increased	2.4% 2/82 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Blood pressure increased	3.7% 3/82 • Number of events 3 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Creatinine renal clearance decreased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Creatinine renal clearance increased	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Electrocardiogram abnormal	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Eosinophil count increased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Haematocrit decreased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Haematocrit increased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Haemoglobin decreased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	2.4% 2/82 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Haemoglobin increased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Hepatic enzyme increased	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Lymphocyte count decreased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Lymphocyte count increased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Neutrophil count increased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Norovirus test positive	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Transaminases increased	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Tri-iodothyronine free increased	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Weight decreased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations Weight increased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations White blood cell count decreased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Investigations White blood cell count increased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Metabolism and nutrition disorders Fluid retention	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Musculoskeletal and connective tissue disorders Arthralgia	2.4% 2/82 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	3.7% 3/81 • Number of events 3 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Musculoskeletal and connective tissue disorders Metatarsalgia	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Musculoskeletal and connective tissue disorders Pain in extremity	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	2.5% 2/81 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Nervous system disorders Dizziness	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Nervous system disorders Headache	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	2.4% 2/82 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	2.4% 2/82 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	2.5% 2/81 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	4.9% 4/81 • Number of events 4 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Nervous system disorders Migraine	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Nervous system disorders Sciatica	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Nervous system disorders Somnolence	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Psychiatric disorders Anxiety	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Psychiatric disorders Bruxism	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Psychiatric disorders Confusional state	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Psychiatric disorders Insomnia	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Psychiatric disorders Persistent depressive disorder	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Psychiatric disorders Suicidal ideation	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Renal and urinary disorders Micturition frequency decreased	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Renal and urinary disorders Renal failure	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Renal and urinary disorders Urethral stenosis	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	2.5% 2/81 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Reproductive system and breast disorders Fibrocystic breast disease	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Respiratory, thoracic and mediastinal disorders Dysphonia	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	2.4% 2/82 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Respiratory, thoracic and mediastinal disorders Respiratory tract congestion	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	2.4% 2/82 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Respiratory, thoracic and mediastinal disorders Wheezing	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Skin and subcutaneous tissue disorders Ecchymosis	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Skin and subcutaneous tissue disorders Rash	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Surgical and medical procedures Abdominal hernia repair	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Surgical and medical procedures Mole excision	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Surgical and medical procedures Umbilical hernia repair	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/81 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Vascular disorders Hot flush	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Vascular disorders Hypertension	4.9% 4/82 • Number of events 4 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	2.4% 2/82 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	3.7% 3/81 • Number of events 3 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	3.7% 3/81 • Number of events 3 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.
Vascular disorders Orthostatic hypotension	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/82 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	1.2% 1/82 • Number of events 1 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	0.00% 0/81 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.	2.5% 2/81 • Number of events 2 • Up to 12 weeks after first intake of medication after randomization. The treatment-emergent adverse events were defined as those adverse events with onset on or after the first day of double-blind study treatment intake up to the last day of double-blind study treatment intake plus 30 days.

Additional Information

Clinical Trial Disclosure Desk

Idorsia Pharmaceuticals Ltd

Phone: +41 58 844 19 77

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place