Trial Outcomes & Findings for A Study of the Efficacy and Safety of MEDI7352 in Participants With Painful Osteoarthritis of the Knee (NCT NCT04675034)

Last Updated: 2025-02-10

Results Overview

Change from baseline in weekly average of daily NRS pain score to Week 12 is reported. The NRS is an 11-point Likert scale used to assess pain, where participants were asked to describe their average pain in the target knee by identifying a number from 0 = "no pain" to 10 = "most severe pain imaginable over the previous 24 hours". This was recorded on a daily basis at approximately the same time every morning via electronic patient recorded outcome (ePRO) diary. A two-step multiple imputation procedure was used to address missing post-baseline scores.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

345 participants

Primary outcome timeframe

Baseline (Day -7 to Day -1, inclusive) through Week 12

Results posted on

2025-02-10

Participant Flow

The study was conducted at 50 sites in 6 countries (the United Kingdom, Denmark, Estonia, Germany, Poland, and Spain).

A total of 345 participants were randomized, of which 344 participants received at least one dose of study drug.

Participant milestones

Participant milestones
Measure	MEDl7352 Dose Level 1 Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Overall Study STARTED	70	68	69	68	70
Overall Study Treated	70	68	69	68	69
Overall Study COMPLETED	59	64	65	57	61
Overall Study NOT COMPLETED	11	4	4	11	9

Reasons for withdrawal

Reasons for withdrawal
Measure	MEDl7352 Dose Level 1 Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Overall Study Lost to Follow-up	1	1	0	2	0
Overall Study Protocol Violation	1	0	0	1	3
Overall Study Withdrawal by Subject	9	3	4	8	6

Baseline Characteristics

A Study of the Efficacy and Safety of MEDI7352 in Participants With Painful Osteoarthritis of the Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MEDl7352 Dose Level 1 n=70 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=69 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=70 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.	Total n=345 Participants Total of all reporting groups
Age, Continuous	65.8 Years STANDARD_DEVIATION 7.90 • n=5 Participants	63.3 Years STANDARD_DEVIATION 7.73 • n=7 Participants	63.8 Years STANDARD_DEVIATION 6.91 • n=5 Participants	63.3 Years STANDARD_DEVIATION 7.52 • n=4 Participants	62.5 Years STANDARD_DEVIATION 8.03 • n=21 Participants	63.7 Years STANDARD_DEVIATION 7.67 • n=8 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	51 Participants n=7 Participants	48 Participants n=5 Participants	46 Participants n=4 Participants	42 Participants n=21 Participants	230 Participants n=8 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	17 Participants n=7 Participants	21 Participants n=5 Participants	22 Participants n=4 Participants	28 Participants n=21 Participants	115 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	5 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	69 Participants n=5 Participants	67 Participants n=7 Participants	67 Participants n=5 Participants	67 Participants n=4 Participants	70 Participants n=21 Participants	340 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	9 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) White	69 Participants n=5 Participants	66 Participants n=7 Participants	67 Participants n=5 Participants	65 Participants n=4 Participants	67 Participants n=21 Participants	334 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline (Day -7 to Day -1, inclusive) through Week 12

Population: Full analysis set (FAS) included all randomized participants analyzed according to the intent-to-treat principle whereby randomized study treatment will be analyzed regardless of the study treatment actually received.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=70 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=69 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=70 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Change From Baseline in Weekly Average of Daily Numerical Rating Scale (NRS) Pain Score to Week 12	-2.19 Unit on a scale Standard Deviation 2.243	-3.00 Unit on a scale Standard Deviation 2.342	-2.83 Unit on a scale Standard Deviation 2.522	-2.81 Unit on a scale Standard Deviation 2.835	-2.35 Unit on a scale Standard Deviation 2.364

SECONDARY outcome

Timeframe: Week 0 (Day 1; baseline) through Week 12

The WOMAC multiscale index is used to assess pain, stiffness, and joint functionality in the past 48 hours in participants with OA of the knee or hip. The WOMAC pain subscale consists of 5 questions assessing the participant's pain due to osteoarthritis (OA) in the target knee. Each question was scored on a NRS scale from 0 to 10, and the WOMAC pain subscale score is calculated as the mean score from all 5 questions, where higher scores represent higher pain. Change from baseline in WOMAC pain subscale to Week 12 is reported. A two-step multiple imputation procedure was used to address missing post-baseline scores.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=70 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=69 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=70 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale to Week 12	-1.88 Unit on a scale Standard Deviation 2.047	-2.88 Unit on a scale Standard Deviation 2.407	-2.62 Unit on a scale Standard Deviation 2.305	-2.57 Unit on a scale Standard Deviation 2.992	-2.62 Unit on a scale Standard Deviation 2.558

SECONDARY outcome

Timeframe: Week 0 (Day 1; baseline) through Week 12

The WOMAC multiscale index is used to assess pain, stiffness, and joint functionality in the past 48 hours in participants with OA of the knee or hip. The WOMAC physical function (PF) subscale consists of 17 questions assessing the participant's difficulty in performing activities of daily living due to OA in the target knee. Each question is scored on an NRS scale from 0 to 10, and the WOMAC PF subscale score is calculated as the mean score from all 17 questions, where higher scores represent worse function. Change from baseline in WOMAC physical function to Week 12 is reported. A two-step multiple imputation procedure was used to address missing post-baseline scores.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=70 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=69 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=70 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Change From Baseline in WOMAC Physical Function Subscale to Week 12	-1.48 Unit on a scale Standard Deviation 2.233	-2.56 Unit on a scale Standard Deviation 2.352	-2.45 Unit on a scale Standard Deviation 1.909	-2.22 Unit on a scale Standard Deviation 2.887	-2.14 Unit on a scale Standard Deviation 2.338

SECONDARY outcome

Timeframe: Week 0 (Day 1; baseline) through Week 12

The PGA of OA was a 5-point Likert scale used to assess symptoms and activity impairment due to OA of the knee. Participants were asked to identify a number from 1 = "very good (asymptomatic and no limitation to normal activities)" to 5 = "very poor (very severe symptoms which are intolerable and inability to carry out all normal activities)" based on the question "Considering all the ways that OA of the knee affects you, how are you feeling today?". Change from baseline in PGA of OA to Week 12 is reported. A two-step multiple imputation procedure was used to address missing post-baseline scores.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=70 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=69 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=70 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Change From Baseline in Patient's Global Assessment (PGA) of OA to Week 12	-0.34 Unit on a scale Standard Deviation 0.933	-0.72 Unit on a scale Standard Deviation 1.123	-0.81 Unit on a scale Standard Deviation 1.032	-0.69 Unit on a scale Standard Deviation 1.377	-0.57 Unit on a scale Standard Deviation 1.003

SECONDARY outcome

Timeframe: Baseline (Week 0; Day 1), Weeks 2 (Day 14), 4 (Day 28), 6 (Day 42), 8 (Day 56), 10 (Day 70), and 18 (Day 126)

Population: FAS included all randomized participants analyzed according to the intent-to-treat principle whereby randomized study treatment will be analyzed regardless of the study treatment actually received. Number of participants analyzed (N) denotes the number of participants evaluated for this outcome measure. Number analyzed (n) denotes those participants who were evaluable at the specified time point.

The WOMAC multiscale index is used to assess pain, stiffness, and joint functionality in the past 48 hours in participants with OA of the knee or hip. The WOMAC pain subscale consists of 5 questions assessing the participant's pain due to OA in the target knee. Each question was scored on an NRS scale from 0 to 10, and the WOMAC pain subscale score is calculated as the mean score from all 5 questions, where higher scores represent higher pain. Change from baseline in WOMAC pain subscale to Weeks 2, 4,6, 8, 10, and 18 is reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=63 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=63 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=63 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=65 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=61 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Change From Baseline in WOMAC Pain Subscale Over Time Week 2	-1.32 Unit on a scale Standard Deviation 1.501	-1.79 Unit on a scale Standard Deviation 1.988	-1.58 Unit on a scale Standard Deviation 1.571	-1.88 Unit on a scale Standard Deviation 1.953	-1.30 Unit on a scale Standard Deviation 1.968
Change From Baseline in WOMAC Pain Subscale Over Time Week 6	-2.01 Unit on a scale Standard Deviation 1.541	-2.76 Unit on a scale Standard Deviation 2.223	-2.73 Unit on a scale Standard Deviation 1.852	-3.07 Unit on a scale Standard Deviation 2.065	-2.40 Unit on a scale Standard Deviation 2.114
Change From Baseline in WOMAC Pain Subscale Over Time Week 10	-2.14 Unit on a scale Standard Deviation 1.886	-3.22 Unit on a scale Standard Deviation 2.282	-2.89 Unit on a scale Standard Deviation 2.052	-3.54 Unit on a scale Standard Deviation 2.055	-2.89 Unit on a scale Standard Deviation 2.283
Change From Baseline in WOMAC Pain Subscale Over Time Week 4	-1.62 Unit on a scale Standard Deviation 1.635	-2.33 Unit on a scale Standard Deviation 2.230	-2.41 Unit on a scale Standard Deviation 1.939	-2.60 Unit on a scale Standard Deviation 2.077	-2.08 Unit on a scale Standard Deviation 2.000
Change From Baseline in WOMAC Pain Subscale Over Time Week 8	-2.01 Unit on a scale Standard Deviation 1.840	-2.96 Unit on a scale Standard Deviation 2.259	-2.91 Unit on a scale Standard Deviation 1.954	-3.33 Unit on a scale Standard Deviation 1.964	-2.56 Unit on a scale Standard Deviation 2.431
Change From Baseline in WOMAC Pain Subscale Over Time Week 18	-2.00 Unit on a scale Standard Deviation 2.090	-3.02 Unit on a scale Standard Deviation 2.388	-2.61 Unit on a scale Standard Deviation 2.107	-3.50 Unit on a scale Standard Deviation 1.988	-2.97 Unit on a scale Standard Deviation 2.219

SECONDARY outcome

Timeframe: Baseline (Week 0; Day 1), Weeks 2 (Day 14), 4 (Day 28), 6 (Day 42), 8 (Day 56), 10 (Day 70), and 18 (Day 126)

The WOMAC multiscale index is used to assess pain, stiffness, and joint functionality in the past 48 hours in participants with OA of the knee or hip. The WOMAC PF subscale consists of 17 questions assessing the participant's difficulty in performing activities of daily living due to OA in the target knee. Each question is scored on an NRS scale from 0 to 10, and the WOMAC PF subscale score is calculated as the mean score from all 17 questions, where higher scores represent worse function. Change from baseline in WOMAC physical function to Weeks 2, 4, 6, 8, 10, and 18 is reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=63 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=63 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=63 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=65 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=61 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Change From Baseline in WOMAC PF Subscale Over Time Week 2	-1.06 Unit on a scale Standard Deviation 1.621	-1.64 Unit on a scale Standard Deviation 1.877	-1.56 Unit on a scale Standard Deviation 1.417	-1.80 Unit on a scale Standard Deviation 1.778	-0.96 Unit on a scale Standard Deviation 1.728
Change From Baseline in WOMAC PF Subscale Over Time Week 4	-1.59 Unit on a scale Standard Deviation 1.812	-2.07 Unit on a scale Standard Deviation 1.933	-2.20 Unit on a scale Standard Deviation 1.701	-2.39 Unit on a scale Standard Deviation 2.062	-1.62 Unit on a scale Standard Deviation 1.708
Change From Baseline in WOMAC PF Subscale Over Time Week 6	-1.77 Unit on a scale Standard Deviation 1.670	-2.43 Unit on a scale Standard Deviation 1.946	-2.43 Unit on a scale Standard Deviation 1.436	-2.71 Unit on a scale Standard Deviation 2.001	-1.92 Unit on a scale Standard Deviation 1.945
Change From Baseline in WOMAC PF Subscale Over Time Week 8	-1.64 Unit on a scale Standard Deviation 1.856	-2.82 Unit on a scale Standard Deviation 1.960	-2.68 Unit on a scale Standard Deviation 1.792	-3.06 Unit on a scale Standard Deviation 1.858	-2.06 Unit on a scale Standard Deviation 2.114
Change From Baseline in WOMAC PF Subscale Over Time Week 10	-1.74 Unit on a scale Standard Deviation 1.994	-2.85 Unit on a scale Standard Deviation 1.944	-2.65 Unit on a scale Standard Deviation 1.671	-3.30 Unit on a scale Standard Deviation 1.979	-2.26 Unit on a scale Standard Deviation 2.063
Change From Baseline in WOMAC PF Subscale Over Time Week 18	-1.55 Unit on a scale Standard Deviation 2.267	-2.71 Unit on a scale Standard Deviation 2.141	-2.37 Unit on a scale Standard Deviation 1.722	-3.17 Unit on a scale Standard Deviation 1.812	-2.24 Unit on a scale Standard Deviation 1.810

SECONDARY outcome

Timeframe: Baseline (Week 0; Day 1), Weeks 2 (Day 14), 4 (Day 28), 6 (Day 42), 8 (Day 56), 10 (Day 70), 12 (Day 84), and 18 (Day 126)

The WOMAC overall score consisted of all 24 questions reported in the WOMAC questionnaire to assess: i) pain subscale, ii) PF subscale and iii) stiffness subscale. WOMAC overall score was calculated as the mean score from all 24 questions each scored on a Likert scale from 0 to 10 where higher scores represent worse outcome. Change from baseline in weekly average of WOMAC overall score to Weeks 2, 4, 6, 8, 10, 12, and 18 is reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=64 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=63 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=64 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=65 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=61 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Change From Baseline in WOMAC Overall Score Over Time Week 2	-1.11 Unit on a scale Standard Deviation 1.546	-1.71 Unit on a scale Standard Deviation 1.836	-1.58 Unit on a scale Standard Deviation 1.343	-1.88 Unit on a scale Standard Deviation 1.735	-1.04 Unit on a scale Standard Deviation 1.695
Change From Baseline in WOMAC Overall Score Over Time Week 4	-1.66 Unit on a scale Standard Deviation 1.706	-2.14 Unit on a scale Standard Deviation 1.958	-2.25 Unit on a scale Standard Deviation 1.667	-2.45 Unit on a scale Standard Deviation 2.000	-1.74 Unit on a scale Standard Deviation 1.671
Change From Baseline in WOMAC Overall Score Over Time Week 6	-1.85 Unit on a scale Standard Deviation 1.583	-2.54 Unit on a scale Standard Deviation 1.968	-2.52 Unit on a scale Standard Deviation 1.426	-2.79 Unit on a scale Standard Deviation 1.951	-1.98 Unit on a scale Standard Deviation 1.984
Change From Baseline in WOMAC Overall Score Over Time Week 8	-1.75 Unit on a scale Standard Deviation 1.792	-2.85 Unit on a scale Standard Deviation 1.995	-2.69 Unit on a scale Standard Deviation 1.757	-3.12 Unit on a scale Standard Deviation 1.822	-2.19 Unit on a scale Standard Deviation 2.102
Change From Baseline in WOMAC Overall Score Over Time Week 10	-1.86 Unit on a scale Standard Deviation 1.907	-2.94 Unit on a scale Standard Deviation 1.995	-2.72 Unit on a scale Standard Deviation 1.663	-3.35 Unit on a scale Standard Deviation 1.954	-2.43 Unit on a scale Standard Deviation 2.022
Change From Baseline in WOMAC Overall Score Over Time Week 12	-1.82 Unit on a scale Standard Deviation 1.945	-3.00 Unit on a scale Standard Deviation 2.087	-2.76 Unit on a scale Standard Deviation 1.616	-3.48 Unit on a scale Standard Deviation 2.121	-2.56 Unit on a scale Standard Deviation 1.956
Change From Baseline in WOMAC Overall Score Over Time Week 18	-1.68 Unit on a scale Standard Deviation 2.148	-2.78 Unit on a scale Standard Deviation 2.153	-2.46 Unit on a scale Standard Deviation 1.718	-3.24 Unit on a scale Standard Deviation 1.784	-2.42 Unit on a scale Standard Deviation 1.767

SECONDARY outcome

Timeframe: Baseline (Week 0; Day 1), Weeks 2 (Day 14), 4 (Day 28), 6 (Day 42), 8 (Day 56), 10 (Day 70), 12 (Day 84), and 18 (Day 126)

The WOMAC stiffness function subscale consists of 2 questions assessing stiffness due to OA in the target knee. Stiffness is defined as a sensation of decreased ease of movement in the target knee. Each question is scored on an NRS scale from 0 to 10, and the WOMAC stiffness function subscale score is calculated as the mean score from the 2 questions, where higher scores represent higher stiffness. Change from baseline in WOMAC stiffness score to Weeks 2, 4, 6, 8, 10, 12, and 18 is reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=64 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=63 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=64 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=65 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=61 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Change From Baseline in WOMAC Stiffness Scores Over Time Week 6	-2.13 Unit on a scale Standard Deviation 1.837	-2.79 Unit on a scale Standard Deviation 2.307	-2.72 Unit on a scale Standard Deviation 1.871	-2.97 Unit on a scale Standard Deviation 2.428	-2.27 Unit on a scale Standard Deviation 2.314
Change From Baseline in WOMAC Stiffness Scores Over Time Week 8	-1.99 Unit on a scale Standard Deviation 2.125	-2.85 Unit on a scale Standard Deviation 2.260	-2.85 Unit on a scale Standard Deviation 2.103	-3.07 Unit on a scale Standard Deviation 2.104	-2.39 Unit on a scale Standard Deviation 2.633
Change From Baseline in WOMAC Stiffness Scores Over Time Week 10	-2.13 Unit on a scale Standard Deviation 2.060	-2.99 Unit on a scale Standard Deviation 2.277	-2.96 Unit on a scale Standard Deviation 1.977	-3.29 Unit on a scale Standard Deviation 2.091	-2.67 Unit on a scale Standard Deviation 2.329
Change From Baseline in WOMAC Stiffness Scores Over Time Week 12	-2.29 Unit on a scale Standard Deviation 2.034	-3.06 Unit on a scale Standard Deviation 2.380	-3.06 Unit on a scale Standard Deviation 2.040	-3.43 Unit on a scale Standard Deviation 2.407	-2.85 Unit on a scale Standard Deviation 2.372
Change From Baseline in WOMAC Stiffness Scores Over Time Week 18	-2.04 Unit on a scale Standard Deviation 2.192	-2.76 Unit on a scale Standard Deviation 2.401	-2.86 Unit on a scale Standard Deviation 1.988	-3.17 Unit on a scale Standard Deviation 1.797	-2.62 Unit on a scale Standard Deviation 2.152
Change From Baseline in WOMAC Stiffness Scores Over Time Week 2	-1.30 Unit on a scale Standard Deviation 1.887	-2.06 Unit on a scale Standard Deviation 2.015	-1.85 Unit on a scale Standard Deviation 1.927	-2.13 Unit on a scale Standard Deviation 2.020	-0.99 Unit on a scale Standard Deviation 1.805
Change From Baseline in WOMAC Stiffness Scores Over Time Week 4	-1.88 Unit on a scale Standard Deviation 1.938	-2.26 Unit on a scale Standard Deviation 2.146	-2.33 Unit on a scale Standard Deviation 2.127	-2.55 Unit on a scale Standard Deviation 2.368	-1.91 Unit on a scale Standard Deviation 2.009

SECONDARY outcome

Timeframe: Baseline, Weeks 2 (Day 14), 4 (Day 28), 8 (Day 56), 10 (Day 70), and 18 (Day 126)

Population: FAS included all randomized participants analyzed according to the intent-to-treat principle whereby randomized study treatment will be analyzed regardless of the study treatment actually received. Number of participants analyzed (N) denotes the number of participants who were evaluable for the specified outcome measure. Number analyzed (n) denotes those participants who were evaluable at the specified time point.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=62 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=62 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=60 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=65 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=60 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Change From Baseline in PGA of OA Over Time Week 2	-0.35 Unit on a scale Standard Deviation 0.812	-0.56 Unit on a scale Standard Deviation 0.917	-0.67 Unit on a scale Standard Deviation 0.933	-0.42 Unit on a scale Standard Deviation 1.059	-0.37 Unit on a scale Standard Deviation 0.698
Change From Baseline in PGA of OA Over Time Week 4	-0.48 Unit on a scale Standard Deviation 0.738	-0.68 Unit on a scale Standard Deviation 1.066	-0.86 Unit on a scale Standard Deviation 1.043	-0.86 Unit on a scale Standard Deviation 1.106	-0.48 Unit on a scale Standard Deviation 0.792
Change From Baseline in PGA of OA Over Time Week 8	-0.57 Unit on a scale Standard Deviation 0.910	-0.80 Unit on a scale Standard Deviation 1.026	-1.02 Unit on a scale Standard Deviation 1.090	-1.04 Unit on a scale Standard Deviation 1.098	-0.51 Unit on a scale Standard Deviation 0.843
Change From Baseline in PGA of OA Over Time Week 10	-0.42 Unit on a scale Standard Deviation 0.723	-0.76 Unit on a scale Standard Deviation 0.922	-1.02 Unit on a scale Standard Deviation 1.010	-1.06 Unit on a scale Standard Deviation 1.295	-0.67 Unit on a scale Standard Deviation 0.826
Change From Baseline in PGA of OA Over Time Week 18	-0.39 Unit on a scale Standard Deviation 0.655	-0.66 Unit on a scale Standard Deviation 1.022	-0.83 Unit on a scale Standard Deviation 1.117	-1.10 Unit on a scale Standard Deviation 1.294	-0.56 Unit on a scale Standard Deviation 0.700

SECONDARY outcome

Timeframe: Weeks 2 (Day 14), 4 (Day 28), 8 (Day 56), 12 (Day 84), and 18 (Day 126)

The OMERACT-OARSI responder index is calculated from the WOMAC Pain subscale, the WOMAC Physical Function Subscale and the PGA of OA. A participant is classified as a responder if: 1. \>= 2-point absolute change from Baseline to Week X or a \>= 50% improvement is reported in the WOMAC Pain or the PF subscales; 2. At least 2 of the following 3 conditions are true: \>= 1-point absolute change from Baseline to Week X or \>= 20% improvement is reported in the WOMAC Pain subscale, \>= 1-point absolute change from Baseline to Week X or \>= 20% improvement is reported in the WOMAC PF subscale or \>= 1-point absolute change from Baseline to Week X is reported in the PGA of OA. Percentage of responder participants are reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=65 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=64 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=67 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=65 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Percentage of Responder Participants Measured by Osteoarthritis Research Society International (OARSI) Responder Index Using Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Definition Week 4	59.3 Percentage of participants	67.7 Percentage of participants	73.4 Percentage of participants	65.6 Percentage of participants	63.1 Percentage of participants
Percentage of Responder Participants Measured by Osteoarthritis Research Society International (OARSI) Responder Index Using Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Definition Week 2	47.7 Percentage of participants	62.5 Percentage of participants	61.8 Percentage of participants	59.7 Percentage of participants	40.6 Percentage of participants
Percentage of Responder Participants Measured by Osteoarthritis Research Society International (OARSI) Responder Index Using Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Definition Week 8	58.9 Percentage of participants	80.7 Percentage of participants	80.0 Percentage of participants	86.3 Percentage of participants	68.6 Percentage of participants
Percentage of Responder Participants Measured by Osteoarthritis Research Society International (OARSI) Responder Index Using Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Definition Week 12	59.2 Percentage of participants	80.0 Percentage of participants	80.0 Percentage of participants	85.7 Percentage of participants	67.4 Percentage of participants
Percentage of Responder Participants Measured by Osteoarthritis Research Society International (OARSI) Responder Index Using Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) Definition Week 18	55.3 Percentage of participants	78.8 Percentage of participants	72.2 Percentage of participants	80.5 Percentage of participants	70.2 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 2 (Day 14), 4 (Day 28), 8 (Day 56), 12 (Day 84), and 18 (Day 126)

The PGA of OA was a 5-point Likert scale used to assess symptoms and activity impairment due to OA of the knee. Participants were asked to identify a number from 1 = "very good (asymptomatic and no limitation to normal activities)" to 5 = "very poor (very severe symptoms which are intolerable and inability to carry out all normal activities)" based on the question "Considering all the ways that OA of the knee affects you, how are you feeling today?". Percentage of participants with improvement of \>= 2 points in PGA of OA at Weeks 2, 4, 8, 12, and 18 is reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=62 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=62 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=60 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=65 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=60 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Percentage of Participants With Improvement of >= 2 Points in PGA of OA Week 2	9.7 Percentage of participants	9.7 Percentage of participants	16.7 Percentage of participants	12.3 Percentage of participants	7.0 Percentage of participants
Percentage of Participants With Improvement of >= 2 Points in PGA of OA Week 4	8.9 Percentage of participants	26.7 Percentage of participants	24.6 Percentage of participants	22.0 Percentage of participants	6.7 Percentage of participants
Percentage of Participants With Improvement of >= 2 Points in PGA of OA Week 8	17.0 Percentage of participants	23.6 Percentage of participants	25.9 Percentage of participants	28.6 Percentage of participants	4.4 Percentage of participants
Percentage of Participants With Improvement of >= 2 Points in PGA of OA Week 12	10.9 Percentage of participants	18.9 Percentage of participants	20.4 Percentage of participants	32.5 Percentage of participants	7.3 Percentage of participants
Percentage of Participants With Improvement of >= 2 Points in PGA of OA Week 18	2.3 Percentage of participants	20.0 Percentage of participants	22.9 Percentage of participants	25.6 Percentage of participants	4.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day -7 to Day -1, inclusive), Weeks 2 (Day 14), 4 (Day 28), 6 (Day 42), 8 (Day 56), 10 (Day 70), and 18 (Day 126)

The NRS is an 11-point Likert scale used to assess pain, where participants were asked to describe their average pain in the target knee by identifying a number from 0 = "no pain" to 10 = "most severe pain imaginable over the previous 24 hours". This will be recorded on a daily basis at approximately the same time every morning via ePRO diary. Change from baseline in weekly average of daily NRS to Weeks 2, 4, 6, 8, 10, and 18 is reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=66 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=64 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=65 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=66 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=65 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Change From Baseline in Weekly Average of Daily NRS Pain Score Over Time Week 2	-1.62 Unit on a scale Standard Deviation 1.704	-1.86 Unit on a scale Standard Deviation 1.949	-1.97 Unit on a scale Standard Deviation 2.012	-2.26 Unit on a scale Standard Deviation 2.129	-1.10 Unit on a scale Standard Deviation 1.811
Change From Baseline in Weekly Average of Daily NRS Pain Score Over Time Week 4	-1.88 Unit on a scale Standard Deviation 1.653	-2.50 Unit on a scale Standard Deviation 2.163	-2.68 Unit on a scale Standard Deviation 2.177	-2.65 Unit on a scale Standard Deviation 2.333	-1.66 Unit on a scale Standard Deviation 1.854
Change From Baseline in Weekly Average of Daily NRS Pain Score Over Time Week 6	-2.17 Unit on a scale Standard Deviation 1.687	-2.83 Unit on a scale Standard Deviation 2.248	-3.00 Unit on a scale Standard Deviation 2.192	-3.35 Unit on a scale Standard Deviation 2.498	-1.97 Unit on a scale Standard Deviation 2.020
Change From Baseline in Weekly Average of Daily NRS Pain Score Over Time Week 8	-2.27 Unit on a scale Standard Deviation 1.736	-2.91 Unit on a scale Standard Deviation 2.084	-3.09 Unit on a scale Standard Deviation 2.205	-3.45 Unit on a scale Standard Deviation 2.365	-2.18 Unit on a scale Standard Deviation 2.274
Change From Baseline in Weekly Average of Daily NRS Pain Score Over Time Week 10	-2.38 Unit on a scale Standard Deviation 2.001	-3.18 Unit on a scale Standard Deviation 1.930	-3.24 Unit on a scale Standard Deviation 2.294	-3.57 Unit on a scale Standard Deviation 2.274	-2.28 Unit on a scale Standard Deviation 2.047
Change From Baseline in Weekly Average of Daily NRS Pain Score Over Time Week 18	-2.08 Unit on a scale Standard Deviation 2.120	-3.18 Unit on a scale Standard Deviation 2.237	-2.90 Unit on a scale Standard Deviation 2.157	-3.63 Unit on a scale Standard Deviation 2.383	-2.45 Unit on a scale Standard Deviation 1.969

SECONDARY outcome

Timeframe: Baseline (Day -7 to Day -1, inclusive), Weeks 2 (Day 14), 4 (Day 28), 8 (Day 56), 12 (Day 84), and 18 (Day 126)

The NRS is an 11-point Likert scale used to assess pain, where participants were asked to describe their average pain in the target knee by identifying a number from 0 = "no pain" to 10 = "most severe pain imaginable over the previous 24 hours". This will be recorded on a daily basis at approximately the same time every morning via ePRO diary. Percentage of participants with \>= 30% and \>= 50% reductions in weekly average of daily NRS pain score are reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=66 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=64 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=65 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=66 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=65 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Percentage of Participants With >= 30% and >= 50% Reductions in Weekly Average of Daily NRS Pain Score Over Time >=30%: Week 2	34.8 Percentage of participants	34.4 Percentage of participants	41.5 Percentage of participants	43.9 Percentage of participants	21.5 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in Weekly Average of Daily NRS Pain Score Over Time >=30%: Week 4	47.5 Percentage of participants	50.0 Percentage of participants	64.1 Percentage of participants	53.8 Percentage of participants	29.7 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in Weekly Average of Daily NRS Pain Score Over Time >=30%: Week 8	56.4 Percentage of participants	67.8 Percentage of participants	67.2 Percentage of participants	61.5 Percentage of participants	42.3 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in Weekly Average of Daily NRS Pain Score Over Time >=30%: Week 12	58.0 Percentage of participants	76.4 Percentage of participants	65.5 Percentage of participants	72.7 Percentage of participants	47.8 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in Weekly Average of Daily NRS Pain Score Over Time >=30%: Week 18	42.9 Percentage of participants	72.9 Percentage of participants	67.3 Percentage of participants	65.8 Percentage of participants	54.5 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in Weekly Average of Daily NRS Pain Score Over Time >=50%: Week 2	15.2 Percentage of participants	25.0 Percentage of participants	29.2 Percentage of participants	30.3 Percentage of participants	13.8 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in Weekly Average of Daily NRS Pain Score Over Time >=50%: Week 4	24.6 Percentage of participants	32.8 Percentage of participants	40.6 Percentage of participants	36.9 Percentage of participants	15.6 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in Weekly Average of Daily NRS Pain Score Over Time >=50%: Week 8	32.7 Percentage of participants	45.8 Percentage of participants	54.1 Percentage of participants	57.7 Percentage of participants	26.9 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in Weekly Average of Daily NRS Pain Score Over Time >=50%: Week 12	44.0 Percentage of participants	54.5 Percentage of participants	49.1 Percentage of participants	54.5 Percentage of participants	26.1 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in Weekly Average of Daily NRS Pain Score Over Time >=50%: Week 18	26.2 Percentage of participants	54.2 Percentage of participants	50.0 Percentage of participants	52.6 Percentage of participants	29.5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0; Day 1), Weeks 2 (Day 14), 4 (Day 28), 8 (Day 56), 12 (Day 84), and 18 (Day 126)

The WOMAC multiscale index is used to assess pain, stiffness, and joint functionality in the past 48 hours in participants with OA of the knee or hip. The WOMAC pain subscale consists of 5 questions assessing the participant's pain due to OA in the target knee. Each question was scored on an NRS scale from 0 to 10, and the WOMAC pain subscale score is calculated as the mean score from all 5 questions, where higher scores represent higher pain. Percentage of participants with \>= 30% and \>= 50% reductions in WOMAC pain subscale score over time are reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=63 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=63 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=63 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=65 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=61 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Pain Subscale Score Over Time >=30%: Week 2	30.2 Percentage of participants	39.7 Percentage of participants	36.5 Percentage of participants	50.8 Percentage of participants	24.1 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Pain Subscale Score Over Time >=30%: Week 4	40.4 Percentage of participants	54.1 Percentage of participants	61.7 Percentage of participants	61.0 Percentage of participants	47.5 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Pain Subscale Score Over Time >=30%: Week 8	55.6 Percentage of participants	64.3 Percentage of participants	64.9 Percentage of participants	71.4 Percentage of participants	56.5 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Pain Subscale Score Over Time >=30%: Week 12	59.6 Percentage of participants	68.5 Percentage of participants	67.3 Percentage of participants	75.0 Percentage of participants	66.7 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Pain Subscale Score Over Time >=30%: Week 18	51.1 Percentage of participants	70.6 Percentage of participants	62.7 Percentage of participants	76.9 Percentage of participants	69.8 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Pain Subscale Score Over Time >=50%: Week 2	14.3 Percentage of participants	23.8 Percentage of participants	17.5 Percentage of participants	33.8 Percentage of participants	10.3 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Pain Subscale Score Over Time >=50%: Week 4	24.6 Percentage of participants	31.1 Percentage of participants	40.0 Percentage of participants	55.9 Percentage of participants	26.2 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Pain Subscale Score Over Time >=50%: Week 8	35.2 Percentage of participants	46.4 Percentage of participants	49.1 Percentage of participants	57.1 Percentage of participants	34.8 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Pain Subscale Score Over Time >=50%: Week 12	31.9 Percentage of participants	51.9 Percentage of participants	50.0 Percentage of participants	62.5 Percentage of participants	42.9 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Pain Subscale Score Over Time >=50%: Week 18	33.3 Percentage of participants	51.0 Percentage of participants	43.1 Percentage of participants	59.0 Percentage of participants	41.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0; Day 1), Weeks 2 (Day 14), 4 (Day 28), 8 (Day 56), 12 (Day 84), and 18 (Day 126)

The WOMAC PF subscale consists of 17 questions assessing the participant's difficulty in performing activities of daily living due to OA in the target knee. Each question is scored on an NRS scale from 0 to 10, and the WOMAC PF subscale score is calculated as the mean score from all 17 questions, where higher scores represent worse function. Percentage of participants with \>= 30% and \>= 50% reductions in WOMAC physical function subscale over time are reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=63 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=63 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=63 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=65 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=61 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Physical Function Subscale Over Time >=30%: Week 2	30.2 Percentage of participants	42.9 Percentage of participants	39.7 Percentage of participants	47.7 Percentage of participants	22.4 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Physical Function Subscale Over Time >=30%: Week 4	47.4 Percentage of participants	52.5 Percentage of participants	61.7 Percentage of participants	59.3 Percentage of participants	37.7 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Physical Function Subscale Over Time >=30%: Week 8	50.0 Percentage of participants	64.3 Percentage of participants	63.2 Percentage of participants	69.4 Percentage of participants	47.8 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Physical Function Subscale Over Time >=30%: Week 12	42.6 Percentage of participants	72.2 Percentage of participants	67.3 Percentage of participants	72.5 Percentage of participants	54.8 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Physical Function Subscale Over Time >=30%: Week 18	42.2 Percentage of participants	72.5 Percentage of participants	64.7 Percentage of participants	74.4 Percentage of participants	60.5 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Physical Function Subscale Over Time >=50%: Week 2	14.3 Percentage of participants	22.2 Percentage of participants	23.8 Percentage of participants	33.8 Percentage of participants	12.1 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Physical Function Subscale Over Time >=50%: Week 4	28.1 Percentage of participants	31.1 Percentage of participants	41.7 Percentage of participants	54.2 Percentage of participants	19.7 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Physical Function Subscale Over Time >=50%: Week 8	33.3 Percentage of participants	51.8 Percentage of participants	47.4 Percentage of participants	57.1 Percentage of participants	26.1 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Physical Function Subscale Over Time >=50%: Week 12	34.0 Percentage of participants	46.3 Percentage of participants	50.0 Percentage of participants	62.5 Percentage of participants	35.7 Percentage of participants
Percentage of Participants With >= 30% and >= 50% Reductions in WOMAC Physical Function Subscale Over Time >=50%: Week 18	33.3 Percentage of participants	45.1 Percentage of participants	39.2 Percentage of participants	59.0 Percentage of participants	34.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 7; pre-dose on Days 14, 28, 42, 56, and 70; and on Days 74, 77, 84, 126, and 224

Population: Pharmacokinetic (PK) analysis set included participants who received at least one dose of double-blind study treatment per the protocol for whom any post-baseline PK data are available and who did not violate or deviate from the protocol in ways that would significantly affect the PK analyses. Number of participants analyzed (N) denotes those participants who were analyzed for this outcome measure. Number analyzed (n) denotes those participants who had adequate serum samples.

Serum concentration of MEDI7352 is reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=70 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=67 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Serum Concentration of MEDI7352 Day 28	11.025 ng/mL Geometric Coefficient of Variation 853.538	28.332 ng/mL Geometric Coefficient of Variation 2745.856	43.644 ng/mL Geometric Coefficient of Variation 6705.491	222.665 ng/mL Geometric Coefficient of Variation 3963.855	—
Serum Concentration of MEDI7352 Day 7	326.863 ng/mL Geometric Coefficient of Variation 98.989	681.322 ng/mL Geometric Coefficient of Variation 159.914	2149.062 ng/mL Geometric Coefficient of Variation 109.2763	3582.265 ng/mL Geometric Coefficient of Variation 364.200	—
Serum Concentration of MEDI7352 Day 14	50.337 ng/mL Geometric Coefficient of Variation 538.604	144.242 ng/mL Geometric Coefficient of Variation 475.607	379.882 ng/mL Geometric Coefficient of Variation 488.933	650.864 ng/mL Geometric Coefficient of Variation 624.642	—
Serum Concentration of MEDI7352 Day 42	5.895 ng/mL Geometric Coefficient of Variation 846.517	12.375 ng/mL Geometric Coefficient of Variation 2578.767	30.005 ng/mL Geometric Coefficient of Variation 11978.840	116.951 ng/mL Geometric Coefficient of Variation 14993.947	—
Serum Concentration of MEDI7352 Day 56	—	6.625 ng/mL Geometric Coefficient of Variation 2133.678	20.546 ng/mL Geometric Coefficient of Variation 13626.951	85.779 ng/mL Geometric Coefficient of Variation 15987.305	—
Serum Concentration of MEDI7352 Day 70	—	—	17.124 ng/mL Geometric Coefficient of Variation 15147.088	57.042 ng/mL Geometric Coefficient of Variation 18183.372	—
Serum Concentration of MEDI7352 Day 74	10.943 ng/mL Geometric Coefficient of Variation 1833.135	22.074 ng/mL Geometric Coefficient of Variation 4305.129	116.544 ng/mL Geometric Coefficient of Variation 25316.322	551.099 ng/mL Geometric Coefficient of Variation 18558.506	—
Serum Concentration of MEDI7352 Day 77	5.011 ng/mL Geometric Coefficient of Variation 1322.708	9.356 ng/mL Geometric Coefficient of Variation 3099.752	47.108 ng/mL Geometric Coefficient of Variation 39692.068	271.511 ng/mL Geometric Coefficient of Variation 36387.885	—
Serum Concentration of MEDI7352 Day 84	—	—	10.482 ng/mL Geometric Coefficient of Variation 6086.596	43.062 ng/mL Geometric Coefficient of Variation 13640.856	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 7; pre-dose on Days 14, 28, 42, 56, and 70; and on Days 74, 77, 84, 126, and 224

Population: ADA evaluable participants included all participants in the safety analysis set who have a non-missing baseline and at least one non-missing post-baseline ADA results. Number of participants analyzed (N) denotes the number of participants who were evaluable for the specified outcome measure. Number analyzed (n) denotes those participants who had adequate ADA sample.

Number of participants with ADA to MEDI7352 are reported. Treatment-induced ADA positive is defined as ADA negative at baseline and positive at least 1 post-baseline ADA assessment. Treatment-boosted ADA positive is defined as ADA positive at baseline, and the baseline titre is boosted by greater than the variability of the assay (commonly 4-fold) at \>= 1 post-baseline timepoint. Persistent positive is defined as ADA negative at baseline and having at least 2 post-baseline ADA positive assessments (with \>= 16 weeks between first and last positive) or ADA positive at last post-baseline assessment. Transiently positive is defined as ADA negative at baseline and at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=70 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=66 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=67 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=67 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI7352 Treatment-induced ADA positive	52 Participants	49 Participants	42 Participants	52 Participants	6 Participants
Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI7352 Treatment-boosted ADA positive	6 Participants	9 Participants	8 Participants	2 Participants	2 Participants
Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI7352 Persistent positive ADA	43 Participants	39 Participants	33 Participants	42 Participants	4 Participants
Number of Participants With Positive Anti-Drug Antibodies (ADA) to MEDI7352 Transiently positive ADA	9 Participants	10 Participants	9 Participants	10 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 7; pre-dose on Days 14, 28, 42, 56, and 70; and on Days 74, 77, 84, 126, and 224

Population: ADA evaluable participants included all participants in safety analysis set who have non-missing baseline and at least 1 non-missing post-baseline ADA results. Number of participants analyzed (N): number of participants who were ADA positive at baseline and/or post-baseline. Number analyzed (n): participants who had adequate ADA sample.

The ADA titre in participants who were ADA positive at baseline and/or post-baseline is reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=61 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=59 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=52 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=54 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=19 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
ADA Titre in Participants Who Were ADA Positive at Baseline and/or Post-baseline	960.0 Ratio Interval 30.0 to 122880.0	960.0 Ratio Interval 30.0 to 245760.0	960.0 Ratio Interval 30.0 to 15360.0	720.0 Ratio Interval 30.0 to 122880.0	240.0 Ratio Interval 30.0 to 3840.0

SECONDARY outcome

Timeframe: Day 1 through 41 weeks (maximum observed duration)

Population: Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=70 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=69 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=69 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Any TEAEs	51 Participants	45 Participants	54 Participants	51 Participants	41 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Any TESAEs	3 Participants	5 Participants	3 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 1 through 41 weeks (maximum observed duration)

Population: Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.

Number of participants with clinically significant findings in physical examination reported as TEAE are reported. A physical examination included assessments of general appearance, skin, head and neck, examination of the oral cavity for any lesions, lymph nodes, thyroid, abdomen (bowel sounds, liver, and spleen palpation), back (including costovertebral angle tenderness), musculoskeletal/extremities, cardiovascular, and respiratory systems.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=70 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=69 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=69 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Number of Participants With Clinically Significant Findings in Physical Examination Reported as TEAEs	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day -45 to Day -1), Weeks 0 (Day 1), 2 (Day 14), 4 (Day 28), 6 (Day 42), 8 (Day 56), 10 (Day 70), 12 (Day 84), 18 (Day 126), 28 (Day 168), 32 (Day 224), and 36 (Day 252)

Population: Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.

Number of participants with clinically significant abnormal findings in neurological examination is reported. The neurological examination included assessment of mental status, cranial nerves, motor examination (muscle strength and tone), upper and lower extremity deep tendon reflexes, plantar responses, sensory system examination, coordination, and gait.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=70 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=69 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=69 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Number of Participants With Clinically Significant Abnormal Findings in Neurological Examination Baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Findings in Neurological Examination Week 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Findings in Neurological Examination Week 2	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Findings in Neurological Examination Week 4	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Clinically Significant Abnormal Findings in Neurological Examination Week 6	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Findings in Neurological Examination Week 8	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Findings in Neurological Examination Week 10	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Findings in Neurological Examination Week 12	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Findings in Neurological Examination Week 18	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Findings in Neurological Examination Week 28	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Findings in Neurological Examination Week 32	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Findings in Neurological Examination Week 36	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day -45 to Day -1), Weeks 0 (Day 1), 2 (Day 14), 4 (Day 28), 6 (Day 42), 8 (Day 56), 10 (Day 70), 12 (Day 84), 28 (Day 196), and 32 (Day 224)

Population: Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received. Number of participants analyzed (N) denotes the number of participants evaluated for this outcome measure. Number analyzed (n) denotes those participants who were evaluable at the specified time point.

The TNSn, is a semiquantitative clinical assessment of peripheral nervous system function. The TNSn assessment is collected as scores of motor symptom, autonomic symptom, pin sensibility, sensory symptom, and vibration sensibility score. Each neuropathy item is scored on a 0 to 4 scale with total score ranging from 0 to 20. Higher total scores correlate with more severe neuropathy.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=70 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=66 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=69 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=67 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Total Neuropathy Score-Nurse (TNSn) Over Time Baseline	1.5 Unit on a scale Standard Deviation 2.40	1.4 Unit on a scale Standard Deviation 1.94	1.0 Unit on a scale Standard Deviation 1.56	1.2 Unit on a scale Standard Deviation 1.69	1.5 Unit on a scale Standard Deviation 2.02
Total Neuropathy Score-Nurse (TNSn) Over Time Week 0	1.3 Unit on a scale Standard Deviation 1.92	1.7 Unit on a scale Standard Deviation 2.26	1.4 Unit on a scale Standard Deviation 2.03	1.5 Unit on a scale Standard Deviation 2.29	1.8 Unit on a scale Standard Deviation 2.26
Total Neuropathy Score-Nurse (TNSn) Over Time Week 2	1.1 Unit on a scale Standard Deviation 1.84	1.6 Unit on a scale Standard Deviation 2.42	1.2 Unit on a scale Standard Deviation 1.97	1.0 Unit on a scale Standard Deviation 1.70	1.5 Unit on a scale Standard Deviation 2.18
Total Neuropathy Score-Nurse (TNSn) Over Time Week 4	1.0 Unit on a scale Standard Deviation 1.66	1.3 Unit on a scale Standard Deviation 1.98	0.9 Unit on a scale Standard Deviation 1.54	0.9 Unit on a scale Standard Deviation 1.61	1.4 Unit on a scale Standard Deviation 2.16
Total Neuropathy Score-Nurse (TNSn) Over Time Week 6	1.0 Unit on a scale Standard Deviation 1.55	1.4 Unit on a scale Standard Deviation 2.23	0.9 Unit on a scale Standard Deviation 1.73	0.9 Unit on a scale Standard Deviation 1.48	1.5 Unit on a scale Standard Deviation 2.51
Total Neuropathy Score-Nurse (TNSn) Over Time Week 8	1.0 Unit on a scale Standard Deviation 1.65	1.1 Unit on a scale Standard Deviation 1.86	0.6 Unit on a scale Standard Deviation 0.91	0.8 Unit on a scale Standard Deviation 1.62	1.2 Unit on a scale Standard Deviation 1.84
Total Neuropathy Score-Nurse (TNSn) Over Time Week 10	1.1 Unit on a scale Standard Deviation 1.85	1.3 Unit on a scale Standard Deviation 2.06	0.8 Unit on a scale Standard Deviation 1.53	0.7 Unit on a scale Standard Deviation 1.20	1.1 Unit on a scale Standard Deviation 2.10
Total Neuropathy Score-Nurse (TNSn) Over Time Week 12	0.9 Unit on a scale Standard Deviation 1.35	1.2 Unit on a scale Standard Deviation 1.88	0.8 Unit on a scale Standard Deviation 1.37	0.7 Unit on a scale Standard Deviation 1.23	1.1 Unit on a scale Standard Deviation 2.00
Total Neuropathy Score-Nurse (TNSn) Over Time Week 28	1.7 Unit on a scale Standard Deviation 2.25	3.3 Unit on a scale Standard Deviation 2.69	2.5 Unit on a scale Standard Deviation 2.83	0.8 Unit on a scale Standard Deviation 0.92	2.9 Unit on a scale Standard Deviation 2.67
Total Neuropathy Score-Nurse (TNSn) Over Time Week 32	1.5 Unit on a scale Standard Deviation 1.98	1.0 Unit on a scale Standard Deviation 1.50	0.5 Unit on a scale Standard Deviation 0.88	0.9 Unit on a scale Standard Deviation 1.64	1.0 Unit on a scale Standard Deviation 1.98

SECONDARY outcome

Timeframe: Baseline (Day -45 to -1) and Week 12

Change from baseline in weight (kg) to Week 12 is reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=66 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=66 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=65 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=66 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=64 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Change From Baseline in Weight (kg) to Week 12	-0.25 kg Standard Deviation 2.048	0.10 kg Standard Deviation 2.343	0.34 kg Standard Deviation 1.932	-0.03 kg Standard Deviation 1.864	-0.34 kg Standard Deviation 2.004

SECONDARY outcome

Timeframe: Day 1 through 41 weeks (maximum observed duration)

Population: Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.

Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormalfinding in the vital sign parameters (body temperature, supine and standing blood pressure, pulse rate, and respiratory rate).

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=70 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=69 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=69 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Number of Participants With Abnormal Vital Signs Reported as TEAEs Bradycardia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs Tachycardia	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs Tachycardia paroxysmal	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs Hypertension	0 Participants	2 Participants	3 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs Hypertensive crisis	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs Orthostatic hypotension	1 Participants	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Vital Signs Reported as TEAEs Pyrexia	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1; Week 0) and Day 252 (Week 36)

Population: Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received. Number of participants analyzed (N) denotes the number of participants who were evaluable for the specified outcome measure. Number analyzed (n) denotes those participants who had adequate SAS impact score.

The SAS is an instrument that measures autonomic symptoms used for assessing autonomic neuropathies in clinical trials. The SAS scale evaluates the presence of symptoms and the degree of severity. The SAS consists of 11 questions in women and 12 questions in men. Each question has a Yes or No answer to symptoms occurring 6 months prior to investigational product (IP) administration. Questions answered with "Yes" are further rated by asking the participant how much each symptom is bothering him or her. Each answer is scored on a scale from 1 to 5 where 1 = not at all and 5 = a lot, and a total symptom impact score is determined. The SAS total impact score is the total of the scores from each question (11 for women and 12 for men). The minimum score is 0 and the maximum is 55 for women and 60 for men. A higher score indicates worse autonomic dysfunction.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=40 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=42 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=44 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=38 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=44 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Change From Baseline in Survey of Autonomic Symptoms (SAS) Total Impact Score	-1.5 Unit on a scale Standard Deviation 4.78	-1.1 Unit on a scale Standard Deviation 4.63	-0.9 Unit on a scale Standard Deviation 4.13	-1.6 Unit on a scale Standard Deviation 4.62	-0.8 Unit on a scale Standard Deviation 3.50

SECONDARY outcome

Timeframe: Weeks 0 (Day 1), 2 (Day 14), 4 (Day 28), 8 (Day 56), 10 (Day 70), 12 (Day 84), 28 (Day 168), and 32 (Day 224)

Population: Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received. Number of participants analyzed (N) denotes the number of participants who were evaluable for the specified outcome measure. Number analyzed (n) denotes those participants who were evaluable at the specified time point.

Number of participants with clinically significant abnormal ECGs are reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=70 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=69 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=69 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Week 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Week 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Week 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Week 8	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Week 10	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Week 12	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Week 28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Week 32	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1 through 41 weeks (maximum observed duration)

Population: Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.

Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=70 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=69 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=69 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Leukocyturia	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs COVID-19	16 Participants	5 Participants	10 Participants	12 Participants	8 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Anaemia	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Leukopenia	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Lymphopenia	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Neutropenia	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Hypercholesterolaemia	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Hyperkalaemia	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Hypertriglyceridaemia	1 Participants	0 Participants	0 Participants	2 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Hypokalaemia	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Hyponatraemia	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Type 2 diabetes mellitus	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Vitamin D deficiency	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Glycosuria	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Proteinuria	0 Participants	0 Participants	2 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Activated partial thromboplastin time prolonged	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Alanine aminotransferase increased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Aspartate aminotransferase increased	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Blood creatine phosphokinase increased	2 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Blood folate decreased	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Blood glucose increased	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Blood uric acid increased	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs C-reactive protein increased	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Coagulation factor increased	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Gamma-glutamyltransferase increased	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs Glycosylated haemoglobin increased	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day -7 to -1, inclusive) and Week 12

Change from baseline in C-reactive protein level to Week 12 is reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=50 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=55 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=54 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=43 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=45 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Change From Baseline in C-reactive Protein Level to Week 12	-2.55 mg/L Standard Deviation 1.975	-3.34 mg/L Standard Deviation 2.004	-3.30 mg/L Standard Deviation 2.422	-3.68 mg/L Standard Deviation 2.313	-2.38 mg/L Standard Deviation 1.971

SECONDARY outcome

Timeframe: Day 1 through 41 weeks (maximum observed duration)

Population: Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.

Number of participants with injection site reactions are reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=70 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=69 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=69 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Number of Participants With Injection Site Reactions	2 Participants	3 Participants	0 Participants	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day -45 to -1) and Week 32

Population: Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.

Number of participants with abnormal X-ray and/or MRI of large joints is reported.

Outcome measures

Outcome measures
Measure	MEDl7352 Dose Level 1 n=70 Participants Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 2 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 3 n=69 Participants Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDl7352 Dose Level 4 n=68 Participants Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=69 Participants Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Number of Participants With Abnormal X-ray and/or Magnetic Resonance Imaging (MRI) of Large Joints X-ray	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Number of Participants With Abnormal X-ray and/or Magnetic Resonance Imaging (MRI) of Large Joints MRI	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

MEDI7352 Dose Level 1

Serious events: 3 serious events

Other events: 51 other events

Deaths: 0 deaths

MEDI7352 Dose Level 2

Serious events: 5 serious events

Other events: 45 other events

Deaths: 0 deaths

MEDI7352 Dose Level 3

Serious events: 3 serious events

Other events: 54 other events

Deaths: 0 deaths

MEDI7352 Dose Level 4

Serious events: 1 serious events

Other events: 51 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MEDI7352 Dose Level 1 n=70 participants at risk Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDI7352 Dose Level 2 n=68 participants at risk Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDI7352 Dose Level 3 n=69 participants at risk Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDI7352 Dose Level 4 n=68 participants at risk Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=69 participants at risk Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Injury, poisoning and procedural complications Multiple injuries	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Splenic rupture	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Traumatic renal injury	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Liver function test abnormal	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Blood and lymphatic system disorders Anaemia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian neoplasm	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Renal and urinary disorders Loss of bladder sensation	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Renal and urinary disorders Nephrolithiasis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Renal and urinary disorders Urinoma	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Henoch-schonlein purpura	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Large intestine polyp	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Covid-19	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Cardiac disorders Cardiovascular insufficiency	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.

Other adverse events

Other adverse events
Measure	MEDI7352 Dose Level 1 n=70 participants at risk Participants received 6 doses of subcutaneous (SC) MEDl7352 Dose Level 1 injection once every 2 weeks (Q2W) during a 12-week parallel-group treatment period.	MEDI7352 Dose Level 2 n=68 participants at risk Participants received 6 doses of SC MEDl7352 Dose Level 2 injection Q2W during a 12-week parallel-group treatment period.	MEDI7352 Dose Level 3 n=69 participants at risk Participants received 6 doses of SC MEDl7352 Dose Level 3 injection Q2W during a 12-week parallel-group treatment period.	MEDI7352 Dose Level 4 n=68 participants at risk Participants received 6 doses of SC MEDl7352 Dose Level 4 injection Q2W during a 12-week parallel-group treatment period.	Placebo n=69 participants at risk Participants received 6 doses of SC placebo injection matched to MEDl7352 Q2W during a 12-week parallel-group treatment period.
Investigations C-reactive protein increased	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Coagulation factor increased	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Cardiac disorders Extrasystoles	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Lower respiratory tract infection	2.9% 2/70 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.3% 3/69 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Nasopharyngitis	8.6% 6/70 • Number of events 7 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	5.9% 4/68 • Number of events 4 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	8.7% 6/69 • Number of events 7 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	7.4% 5/68 • Number of events 5 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	13.0% 9/69 • Number of events 11 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Oral herpes	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Periodontitis	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Pharyngitis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Pulpitis dental	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Respiratory syncytial virus infection	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Respiratory tract infection	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.4% 3/68 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Respiratory tract infection viral	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Rhinitis	2.9% 2/70 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Cardiac disorders Mitral valve incompetence	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Sinusitis	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Skin infection	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Upper respiratory tract infection	2.9% 2/70 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.4% 3/68 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	5.8% 4/69 • Number of events 4 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.4% 3/68 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Urinary tract infection	2.9% 2/70 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	7.4% 5/68 • Number of events 6 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 4 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	5.9% 4/68 • Number of events 6 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Viral upper respiratory tract infection	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Accidental exposure to product	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Adverse event following immunisation	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Animal bite	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Back injury	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Cardiac disorders Palpitations	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Bone contusion	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Cartilage injury	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Chillblains	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Contusion	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Fall	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Fracture	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Head injury	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Joint injury	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.3% 3/69 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Cardiac disorders Tachycardia	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Limb injury	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Muscle injury	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Muscle strain	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Musculoskeletal injury	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Post procedural contusion	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Post-traumatic pain	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Skin injury	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Soft tissue injury	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Cardiac disorders Tachycardia paroxysmal	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Injury, poisoning and procedural complications Tooth fracture	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Alanine aminotransferase increased	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Aspartate aminotransferase increased	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Blood creatine phosphokinase increased	2.9% 2/70 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Blood folate decreased	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Blood glucose increased	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Blood pressure increased	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Congenital, familial and genetic disorders Accessory spleen	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Blood uric acid increased	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Drug screen positive	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Electrocardiogram qt prolonged	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Electrocardiogram t wave inversion	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Faecal calprotectin abnormal	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Gamma-glutamyltransferase increased	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Glycosylated haemoglobin increased	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Congenital, familial and genetic disorders Vascular malformation	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Investigations Liver function test increased	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hypercholesterolaemia	1.4% 1/70 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hypertriglyceridaemia	1.4% 1/70 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Metabolism and nutrition disorders Vitamin d deficiency	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 7/70 • Number of events 7 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	8.8% 6/68 • Number of events 7 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	7.2% 5/69 • Number of events 5 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.4% 3/68 • Number of events 6 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	5.8% 4/69 • Number of events 4 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Ear and labyrinth disorders Ear congestion	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Back pain	4.3% 3/70 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	7.2% 5/69 • Number of events 5 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	10.3% 7/68 • Number of events 9 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.3% 3/69 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Facet joint syndrome	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Intervertebral disc degeneration	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Limb mass	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Muscle spasms	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.4% 3/68 • Number of events 5 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Ear and labyrinth disorders Tinnitus	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Myalgia	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.4% 3/68 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.3% 3/69 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Rapidly progressive osteoarthritis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Soft tissue disorder	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Subchondral insufficiency fracture	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Tendon pain	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Musculoskeletal and connective tissue disorders Trigger finger	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acrochordon	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Blood and lymphatic system disorders Anaemia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Ear and labyrinth disorders Vertigo	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.4% 3/68 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of bone	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour ulceration	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Areflexia	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Burning sensation	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Ear and labyrinth disorders Vertigo positional	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Carpal tunnel syndrome	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Cervical radiculopathy	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Disturbance in attention	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Dizziness	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.3% 3/69 • Number of events 4 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Dizziness postural	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Headache	2.9% 2/70 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	10.3% 7/68 • Number of events 8 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	13.0% 9/69 • Number of events 9 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	13.2% 9/68 • Number of events 11 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.3% 3/69 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Hypoaesthesia	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	5.8% 4/69 • Number of events 4 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 4 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Migraine	1.4% 1/70 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Paraesthesia	5.7% 4/70 • Number of events 5 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.4% 3/68 • Number of events 4 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	5.9% 4/68 • Number of events 5 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Polyneuropathy	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Endocrine disorders Goitre	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Presyncope	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Resting tremor	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Sciatica	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Sensory loss	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Somnolence	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Nervous system disorders Tremor	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Psychiatric disorders Alcohol abuse	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Psychiatric disorders Anxiety	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Psychiatric disorders Depressed mood	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Psychiatric disorders Depression	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Eye disorders Amaurosis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Psychiatric disorders Insomnia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Psychiatric disorders Irritability	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Renal and urinary disorders Dysuria	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Renal and urinary disorders Glycosuria	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Renal and urinary disorders Leukocyturia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Renal and urinary disorders Micturition urgency	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Renal and urinary disorders Proteinuria	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Renal and urinary disorders Renal cyst	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Eye disorders Conjunctival haemorrhage	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Renal and urinary disorders Urinary incontinence	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Renal and urinary disorders Urinary retention	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Renal and urinary disorders Urinary tract inflammation	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Reproductive system and breast disorders Bartholin's cyst	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Reproductive system and breast disorders Pelvic pain	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Aphonia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Cough	7.1% 5/70 • Number of events 5 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Eye disorders Glaucoma	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.4% 3/68 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Eye disorders Lacrimation increased	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Dermal cyst	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Miliaria	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Pruritus	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	5.8% 4/69 • Number of events 4 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Eye disorders Photopsia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Pustular psoriasis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Rash	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Rosacea	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Vascular disorders Hot flush	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Vascular disorders Hypertension	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.3% 3/69 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Vascular disorders Hypertensive crisis	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Vascular disorders Orthostatic hypotension	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Vascular disorders Peripheral coldness	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Vascular disorders Superficial vein prominence	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Eye disorders Vitreous floaters	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Blood and lymphatic system disorders Leukopenia	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Abdominal mass	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Abdominal pain	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Colitis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Constipation	2.9% 2/70 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Dental discomfort	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Diarrhoea	4.3% 3/70 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Diverticulum intestinal	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Duodenitis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Dyspepsia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Food poisoning	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Gastric ulcer	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Gastritis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Hiatus hernia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Mesenteric panniculitis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Nausea	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Noninfective gingivitis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Oesophagitis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Tongue discomfort	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Toothache	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Gastrointestinal disorders Vomiting	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Asthenia	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Chest discomfort	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Chills	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Fatigue	2.9% 2/70 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Feeling hot	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Blood and lymphatic system disorders Neutropenia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Influenza like illness	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Injection site bruising	2.9% 2/70 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.3% 3/69 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Injection site erythema	2.9% 2/70 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	8.8% 6/68 • Number of events 8 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	8.7% 6/69 • Number of events 7 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	13.2% 9/68 • Number of events 10 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Injection site induration	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Injection site pain	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	7.4% 5/68 • Number of events 7 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	5.8% 4/69 • Number of events 5 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Injection site pruritus	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Injection site reaction	2.9% 2/70 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.4% 3/68 • Number of events 4 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	5.9% 4/68 • Number of events 7 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Injection site swelling	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Malaise	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Oedema peripheral	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Cardiac disorders Atrial fibrillation	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Peripheral swelling	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Pyrexia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Temperature regulation disorder	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
General disorders Thirst	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Hepatobiliary disorders Cholelithiasis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Hepatobiliary disorders Cholestasis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Hepatobiliary disorders Hepatic lesion	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Hepatobiliary disorders Hepatic steatosis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Hepatobiliary disorders Hepatomegaly	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Cardiac disorders Bradycardia	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Immune system disorders Allergy to arthropod sting	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Immune system disorders Drug hypersensitivity	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Immune system disorders Seasonal allergy	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Immune system disorders Type iv hypersensitivity reaction	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Acarodermatitis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Bronchitis	2.9% 2/70 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.4% 3/68 • Number of events 3 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Covid-19	22.9% 16/70 • Number of events 16 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	7.4% 5/68 • Number of events 5 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	14.5% 10/69 • Number of events 10 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	17.6% 12/68 • Number of events 12 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	11.6% 8/69 • Number of events 8 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Cellulitis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Conjunctivitis	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Cystitis	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	4.3% 3/69 • Number of events 5 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Ear infection	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	2.9% 2/68 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Ear infection fungal	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Epstein-barr virus infection	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Erysipelas	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Fungal skin infection	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Furuncle	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Gastroenteritis	1.4% 1/70 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Gastroenteritis viral	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	1.4% 1/70 • Number of events 2 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.
Infections and infestations Influenza	0.00% 0/70 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/68 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	0.00% 0/69 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.5% 1/68 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.	1.4% 1/69 • Number of events 1 • Day 1 through 41 weeks (maximum observed duration) Safety analysis set included all participants who received at least 1 dose of any double-blind study drug and were analyzed according to the treatment they actually received.

Additional Information

Global Clinical Lead

AstraZeneca Clinical Study Information Center

Phone: +1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AstraZeneca has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Publication restrictions are in place

Restriction type: OTHER